Generic Envarsus XR Availability
Last updated on Apr 10, 2025.
Envarsus XR is a brand name of tacrolimus, approved by the FDA in the following formulation(s):
ENVARSUS XR (tacrolimus - tablet, extended release;oral)
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Manufacturer: VELOXIS PHARMS INC
Approval date: July 10, 2015
Strength(s): EQ 0.75MG BASE [RLD], EQ 1MG BASE [RLD], EQ 4MG BASE [RLD]
Is there a generic version of Envarsus XR available?
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: 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.
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Stabilized tacrolimus composition
Patent 10,166,190
Issued: January 1, 2019
Inventor(s): Skak Nikolaj & Holm Per
Assignee(s): VELOXIS PHARMACEUTICALS A/SThe invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.
Patent expiration dates:
- May 30, 2028✓
- May 30, 2028
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Tacrolimus for improved treatment of transplant patients
Patent 10,864,199
Issued: December 15, 2020
Inventor(s): Gordon Robert D. & Holm Per & Lademann Anne-Marie & Norling Tomas
Assignee(s): VELOXIS PHARMACEUTICALS A/SAn 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✓
- May 30, 2028✓
- May 30, 2028
-
Tacrolimus for improved treatment of transplant patients
Patent 11,110,081
Issued: September 7, 2021
Inventor(s): Gordon; Robert D. et al.
Assignee(s): VELOXIS PHARMACEUTICALS, INC. (Cary, NC)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✓
- May 30, 2028
-
Tacrolimus for improved treatment of transplant patients
Patent 11,123,331
Issued: September 21, 2021
Inventor(s): Gordon Robert D. & Holm Per & Lademann Anne-Marie & Norling Tomas
Assignee(s): VELOXIS PHARMACEUTICALS, INC.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✓
- May 30, 2028
-
Stabilized tacrolimus composition
Patent 11,419,823
Issued: August 23, 2022
Inventor(s): Skak Nikolaj & Holm Per
Assignee(s): VELOXIS PHARMACEUTICALS, INC.The invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.
Patent expiration dates:
- May 30, 2028✓
- May 30, 2028
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Tacrolimus for improved treatment of transplant patients
Patent 12,083,103
Issued: September 10, 2024
Inventor(s): Gordon; Robert D. et al.
Assignee(s): VELOXIS PHARMACEUTICALS, INC. (Cary, NC)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✓
- May 30, 2028
-
Tacrolimus for improved treatment of transplant patients
Patent 8,664,239
Issued: March 4, 2014
Inventor(s): Gordon Robert D. & Holm Per & Lademann Anne-Marie & Norling Tomas
Assignee(s): Veloxis Pharmaceuticals A/SAn 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:
- August 30, 2028✓
- August 30, 2028✓
- August 30, 2028✓
- August 30, 2028
-
Tacrolimus for improved treatment of transplant patients
Patent 8,685,998
Issued: April 1, 2014
Inventor(s): Gordon Robert D. & Holm Per & Lademann Anne-Marie & Norling Tomas
Assignee(s): Veloxis Pharmaceuticals A/SAn 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:
- August 30, 2028✓✓
- August 30, 2028✓✓
- August 30, 2028✓✓
- August 30, 2028
-
Stabilized tacrolimus composition
Patent 9,549,918
Issued: January 24, 2017
Inventor(s): Skak Nikolaj & Holm Per
Assignee(s): VELOXIS PHARMACEUTICALS A/SThe invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.
Patent expiration dates:
- May 30, 2028✓
- May 30, 2028
More about Envarsus XR (tacrolimus)
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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
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