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Generic Bydureon BCise Availability

Last updated on Oct 6, 2021.

Bydureon BCise is a brand name of exenatide, approved by the FDA in the following formulation(s):

BYDUREON BCISE (exenatide synthetic - suspension, extended release;subcutaneous)

  • Manufacturer: ASTRAZENECA AB
    Approval date: October 20, 2017
    Strength(s): 2MG/0.85ML (2MG/0.85ML) [RLD]

Has a generic version of Bydureon BCise been approved?

No. There is currently no therapeutically equivalent version of Bydureon BCise available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bydureon BCise. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • C-aryl glucoside SGLT2 inhibitors and method
    Patent 6,515,117
    Issued: February 4, 2003
    Inventor(s): Bruce; Ellsworth & William N.; Washburn & Philip M.; Sher & Gang; Wu & Wei; Meng
    Assignee(s): Bristol-Myers Squibb Company

    An SGLT2 inhibiting compound is provided having the formula A method is also provided for treating diabetes and related diseases employing an SGLT2 inhibiting amount of the above compound alone or in combination with another antidiabetic agent or other therapeutic agent.

    Patent expiration dates:

    • October 4, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 4, 2026
      ✓ 
      Pediatric exclusivity
  • Residual solvent extraction method and microparticles produced thereby
    Patent 6,824,822
    Issued: November 30, 2004
    Inventor(s): Michael E.; Rickey & J. Michael; Ramstack & Rajesh; Kumar
    Assignee(s): Alkermes Controlled Therapeutics Inc. II

    Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.

    Patent expiration dates:

    • October 9, 2022
      ✓ 
      Drug product
    • April 9, 2023
      ✓ 
      Pediatric exclusivity
  • Residual solvent extraction method and microparticles produced thereby
    Patent 7,223,440
    Issued: May 29, 2007
    Inventor(s): Rickey; Michael E. & Ramstack; J. Michael & Kumar; Rajesh
    Assignee(s): Alkermes, Inc.

    Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.

    Patent expiration dates:

    • August 31, 2021
      ✓ 
      Drug product
    • March 3, 2022
      ✓ 
      Pediatric exclusivity
  • Polymer-based sustained release device
    Patent 7,456,254
    Issued: November 25, 2008
    Inventor(s): Wright; Steven G. & Christenson; Troy & Yeah; Thean Y. & Rickey; Michael E. & Hotz; Joyce M. & Kumar; Rajesh & Costantino; Henry R.
    Assignee(s): Alkermes, Inc.

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • June 30, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
      ✓ 
      Drug product
    • June 30, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
      ✓ 
      Drug product
    • June 30, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
      ✓ 
      Drug product
    • June 30, 2025
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • June 30, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
      ✓ 
      Drug product
    • June 30, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
      ✓ 
      Drug product
    • December 30, 2025
      ✓ 
      Pediatric exclusivity
  • Polymer-based sustained release device
    Patent 7,563,871
    Issued: July 21, 2009
    Inventor(s): Wright; Steven G. & Christensen; Troy & Yeoh; Thean & Rickey; Michael E. & Hotz; Joyce M. & Kumar; Rajesh & Fineman; Mark & Smith; Christine & Ong; John & Lokensgard; David & Costantino; Henry R.
    Assignee(s): Alkermes, Inc. Amylin Pharmaceuticals, Inc.

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 15, 2024
      ✓ 
      Drug product
    • October 15, 2024
      ✓ 
      Pediatric exclusivity
  • Polymer-based sustained release device
    Patent 7,612,176
    Issued: November 3, 2009
    Inventor(s): Wright; Steven G. & Christensen; Troy & Yeoh; Thean & Rickey; Michael E. & Hotz; Joyce M. & Kumar; Rajesh & Costantino; Henry R.
    Assignee(s): Alkermes, Inc.

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
      ✓ 
      Drug product
    • October 13, 2025
      ✓ 
      Pediatric exclusivity
  • Methods for treating diabetes and reducing body weight
    Patent 8,329,648
    Issued: December 11, 2012
    Inventor(s): Fineman; Mark & MacConell; Leigh & Taylor; Kristin
    Assignee(s): Amylin Pharmaceuticals, LLC

    Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.

    Patent expiration dates:

    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
    • August 18, 2026
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
    • August 18, 2026
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
    • February 18, 2027
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical formulations containing an SGLT2 inhibitor
    Patent 8,361,972
    Issued: January 29, 2013
    Assignee(s): Bristol Myers-Squibb Company

    Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

    Patent expiration dates:

    • March 21, 2028
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
    • September 21, 2028
      ✓ 
      Pediatric exclusivity
  • Polymer-based sustained release device
    Patent 8,431,685
    Issued: April 30, 2013
    Assignee(s): Alkermes Pharma Ireland Limited

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
      ✓ 
      Drug product
    • October 13, 2025
      ✓ 
      Pediatric exclusivity
  • Polymer-based sustained release device
    Patent 8,461,105
    Issued: June 11, 2013
    Assignee(s): Alkermes Pharma Ireland Limited

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
      ✓ 
      Drug product
    • April 13, 2025
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • October 13, 2025
      ✓ 
      Pediatric exclusivity
  • Crystal structures of SGLT2 inhibitors and processes for preparing same
    Patent 8,501,698
    Issued: August 6, 2013
    Assignee(s): Bristol-Myers Squibb Company

    The present invention relates to physical crystal structures of a compound of the formula I: wherein R1, R2, R2a, R3 and R4 are as defined herein, especially pharmaceutical compositions containing structures of compound I or II, processes for preparing same, intermediates used in preparing same, and methods of treating diseases such as diabetes using such structures.

    Patent expiration dates:

    • June 20, 2027
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
    • December 20, 2027
      ✓ 
      Pediatric exclusivity
  • Sustained release formulations using non-aqueous carriers
    Patent 8,895,033
    Issued: November 25, 2014
    Assignee(s): Amylin Pharmaceuticals, LLC AstraZeneca Pharmaceuticals LP

    The disclosure provides one-component, injectable, sustained release formulations which comprise microspheres containing active pharmaceutical ingredients (e.g., exenatide), wherein the microspheres are suspended in a non-aqueous carrier. The non-aqueous carrier can be an oil, a fractionated oil, triglycerides, diglycerides, monoglycerides, propylene glycol fatty acid diesters, and the like. The formulations offer distinct advantages of long shelf life for the stability and potency of the formulation and sustained release of active pharmaceutical ingredients to reduce the frequency of medication dosing and to increase patient compliance.

    Patent expiration dates:

    • October 4, 2030
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
      ✓ 
      Drug product
    • October 4, 2030
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
      ✓ 
      Drug product
    • October 4, 2030
      ✓ 
      Patent use: STIMULATING INSULIN RELEASE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • October 4, 2030
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
      ✓ 
      Drug product
    • October 4, 2030
      ✓ 
      Patent use: DELAYING GASTRIC EMPTYING IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • October 4, 2030
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
      ✓ 
      Drug product
    • October 4, 2030
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • October 4, 2030
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
      ✓ 
      Drug product
    • April 4, 2031
      ✓ 
      Pediatric exclusivity
  • Method for treating diabetes
    Patent 8,906,851
    Issued: December 9, 2014
    Assignee(s): Amylin Pharmaceuticals, LLC AstraZeneca Pharmaceuticals LP

    Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.

    Patent expiration dates:

    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
    • August 18, 2026
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
    • February 18, 2027
      ✓ 
      Pediatric exclusivity
  • Polymer-based sustained release device
    Patent 9,238,076
    Issued: January 19, 2016
    Assignee(s): Alkermes Pharma Ireland Limited Amylin Pharmaceuticals, LLC

    This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

    Patent expiration dates:

    • April 15, 2024
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
      ✓ 
      Drug product
    • April 15, 2024
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE TO PROVIDE A RELEASE PROFILE HAVING A RATIO OF C-MAX TO C-AVG OF ABOUT 3 OR LESS
      ✓ 
      Drug product
    • April 15, 2024
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
      ✓ 
      Drug product
    • April 15, 2024
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
      ✓ 
      Drug product
    • April 15, 2024
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
      ✓ 
      Drug product
    • April 15, 2024
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
      ✓ 
      Drug product
    • April 15, 2024
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
      ✓ 
      Drug product
    • April 15, 2024
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
      ✓ 
      Drug product
    • October 15, 2024
      ✓ 
      Pediatric exclusivity
  • Methods for treating diabetes and reducing body weight
    Patent 9,884,092
    Issued: February 6, 2018
    Assignee(s): Amylin Pharmaceuticals, LLC AstraZeneca Pharmaceuticals LP

    Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.

    Patent expiration dates:

    • August 18, 2026
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
    • August 18, 2026
      ✓ 
      Patent use: IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
    • August 18, 2026
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
    • February 18, 2027
      ✓ 
      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • February 15, 2022 - INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES
    • August 15, 2023 - PEDIATRIC EXCLUSIVITY
    • July 22, 2024 - NEW PATIENT POPULATION
    • January 22, 2025 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.