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Generic Astagraf XL Availability

Astagraf XL is a brand name of tacrolimus, approved by the FDA in the following formulation(s):

ASTAGRAF XL (tacrolimus - capsule, extended release;oral)

  • Manufacturer: ASTELLAS
    Approval date: July 19, 2013
    Strength(s): EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE [RLD]

Has a generic version of Astagraf XL been approved?

No. There is currently no therapeutically equivalent version of Astagraf XL available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Astagraf XL. 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: About generic drugs.

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.

  • Sustained release preparations
    Patent 6,440,458
    Issued: August 27, 2002
    Inventor(s): Kazunari; Yamashita & Eiji; Hashimoto & Yukihiro; Nomura & Fumio; Shimojo & Shigeki; Tamura & Takeo; Hirose & Satoshi; Ueda & Takashi; Saitoh & Rinta; Ibuki & Toshio; Ideno
    Assignee(s): Fujisawa Pharmaceutical Co., Ltd.
    Providing an oral formulation of a macrolide compound where the dissolution of the macrolide compound is under sustained release; and a sustained-release formulation containing a composition in solid solution, where the macrolide compound is present at an amorphous state in a solid base.
    Patent expiration dates:
    • March 25, 2019
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      Drug product
  • Sustained release formulations containing tacrolimus
    Patent 6,576,259
    Issued: June 10, 2003
    Inventor(s): Kazunari; Yamashita & Eiji; Hashimoto & Yukihiro; Nomura & Fumio; Shimojo & Shigeki; Tamura & Takeo; Hirose & Satoshi; Ueda & Takashi; Saitoh & Rinta; Ibuki & Toshio; Ideno
    Assignee(s): Fujisawa Pharmaceutical Co., Ltd.
    Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanese Pharmacopoeia, the 13-th edition, Dissolution Test, No. 2 (Puddle method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprise a solid base which is a water-soluble polymer and/or wax. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. Furthermore, the formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune diseases.
    Patent expiration dates:
    • March 25, 2019
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      Patent use: METHOD OF ONCE A DAY ADMINISTRATION
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      Drug product
  • Sustained release formulation containing tacrolimus
    Patent 6,884,433
    Issued: April 26, 2005
    Inventor(s): Yamashita; Kazunari & Hashimoto; Eiji & Nomura; Yukihiro & Shimojo; Fumio & Tamura; Shigeki & Hirose; Takeo & Ueda; Satoshi & Saitoh; Takashi & Ibuki; Rinta & Ideno; Toshio
    Assignee(s): Fujisawa Pharmaceutical Co., Ltd.
    Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanes Pharmacopocia, the 13-th edition, Dissolution Test, No. 2 (Puddles method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprises a solid base which is a water-soluble or water-insoluble polymer. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. The formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune disease. In addition, a solid dispersion composition is provided. The solid dispersion comprises tacrolimus or its hydrate in a mixture containing water-soluble or water-insoluble polymer and an excipient.
    Patent expiration dates:
    • March 25, 2019
      ✓ 
      Patent use: METHOD OF ONCE A DAY ADMINISTRATION
      ✓ 
      Drug product
  • Sustained-release formulation
    Patent 8,551,522
    Issued: October 8, 2013
    Assignee(s): Astellas Pharma Inc.
    A sustained-release formulation is provided comprising a solid dispersion composition comprising a tricyclic compound or a pharmaceutically acceptable salt thereof in a mixture comprising a water-soluble polymer and a water-insoluble polymer, and an excipient.
    Patent expiration dates:
    • March 25, 2019
      ✓ 
      Drug product

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:
    • July 19, 2016 - NEW DOSAGE FORM

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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