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Generic Envarsus XR Availability

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

ENVARSUS XR (tacrolimus - tablet, extended release;oral)

  • Manufacturer: VELOXIS PHARMS INC
    Approval date: July 10, 2015
    Strength(s): EQ 0.75MG BASE, EQ 1MG BASE, EQ 4MG BASE [RLD]

Has a generic version of Envarsus XR been approved?

No. There is currently no therapeutically equivalent version of Envarsus XR available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Envarsus XR. 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.

  • Solid dispersions comprising tacrolimus
    Patent 7,994,214
    Issued: August 9, 2011
    Inventor(s): Holm; Per
    Assignee(s): Lifecycle Pharma A/S
    A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Drug product
  • Solid dispersions comprising tacrolimus
    Patent 8,486,993
    Issued: July 16, 2013
    Assignee(s): Veloxis Pharmaceuticals A/S
    A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
      ✓ 
      Drug product
  • Modified release compositions comprising tacrolimus
    Patent 8,586,084
    Issued: November 19, 2013
    Assignee(s): Veloxis Pharmaceuticals A/S
    A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
  • Modified release compositions comprising tacrolimus
    Patent 8,591,946
    Issued: November 26, 2013
    Assignee(s): Veloxis Pharmaceuticals A/S
    A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Drug product
  • Modified release compositions comprising tacrolimus
    Patent 8,617,599
    Issued: December 31, 2013
    Assignee(s): Veloxis Pharmaceuticals A/S
    A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Drug product
  • Modified release compositions comprising tacrolimus
    Patent 8,623,410
    Issued: January 7, 2014
    Assignee(s): Veloxis Pharmaceuticals A/S
    A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Drug product
  • Modified release compositions comprising tacrolimus
    Patent 8,623,411
    Issued: January 7, 2014
    Assignee(s): Veloxis Pharmaceuticals A/S
    A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
  • Tacrolimus for improved treatment of transplant patients
    Patent 8,664,239
    Issued: March 4, 2014
    Assignee(s): Veloxis Pharmaceuticals A/S
    An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
    Patent expiration dates:
    • May 30, 2028
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
  • Tacrolimus for improved treatment of transplant patients
    Patent 8,685,998
    Issued: April 1, 2014
    Assignee(s): Veloxis Pharmaceuticals A/S
    An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
    Patent expiration dates:
    • May 30, 2028
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
      ✓ 
      Drug product
  • Modified release compositions comprising tacrolimus
    Patent 8,889,185
    Issued: November 18, 2014
    Assignee(s): Veloxis Pharmaceuticals A/S
    A modified release composition comprising tacrolimus which is useful for the treatment or prevention of rejection reactions by transplantation of organs or tissues.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
  • Modified release compositions comprising tacrolimus
    Patent 8,889,186
    Issued: November 18, 2014
    Assignee(s): Veloxis Pharmaceuticals A/S
    A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
  • Modified release compositions comprising tacrolimus
    Patent 9,161,907
    Issued: October 20, 2015
    Assignee(s): VELOXIS PHARMACEUTICALS A/S
    A modified release composition comprising tacrolimus which is useful for the treatment or prevention of rejection reactions by transplantation of organs or tissues.
    Patent expiration dates:
    • August 30, 2024
      ✓ 
      Patent use: PROPHYLAXIS OF ORGAN REJECTION
      ✓ 
      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 10, 2022 - ORPHAN DRUG EXCLUSIVITY

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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