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Mycophenolate Mofetil Patent Expiration

Mycophenolate Mofetil was first introduced by Roche Palo Alto Llc in its drug Cellcept on May 3, 1995. Another drug containing Mycophenolate Mofetil is Myhibbin. 23 different companies have introduced drugs containing Mycophenolate Mofetil.


Mycophenolate Mofetil Patents

Given below is the list of patents protecting Mycophenolate Mofetil, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Myhibbin US11931455 Pharmaceutical suspension for oral dosage Aug 16, 2039 Azurity
Myhibbin US12097284 Mycophenolate oral suspension Aug 16, 2039 Azurity
Myhibbin US12097285 Mycophenolate oral suspension Aug 16, 2039 Azurity
Cellcept US5688529 Mycophenolate mofetil high dose oral suspensions Nov 18, 2014

(Expired)

 Roche Palo



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Mycophenolate Mofetil Generic API Manufacturers

Several generic applications have been filed for Mycophenolate Mofetil. The first generic version for Mycophenolate Mofetil was by Hikma Pharmaceuticals Usa Inc and was approved on Jul 29, 2008. And the latest generic version is by Hetero Labs Ltd Unit V and was approved on Oct 22, 2024.

Given below is the list of companies who have filed for Mycophenolate Mofetil generic, along with the locations of their manufacturing plants worldwide.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB May 4, 2009
250MG

capsule Prescription ORAL AB May 4, 2009





2. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB Nov 4, 2011
250MG

capsule Prescription ORAL AB Jun 13, 2013
200MG/ML

for suspension Prescription ORAL AB Nov 14, 2014





3. AMNEAL

Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A Jul 16, 2010
200MG/ML

for suspension Prescription ORAL AB Nov 2, 2021


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





4. APOTEX

Apotex Inc has filed for 1 generic for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A Apr 22, 2009


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





5. APOTEX CORP

Apotex Corp has filed for 1 generic for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Apotex Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Discontinued ORAL N/A Apr 22, 2009


Manufacturing Plant Locations
New

Apotex Corp's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Apotex Corp as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.





6. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB Feb 20, 2024


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Prescription ORAL AB Jan 5, 2024
200MG/ML

for suspension Prescription ORAL AB Sep 26, 2024


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





8. CONCORD BIOTECH LTD

Concord Biotech Ltd has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Concord Biotech Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Prescription ORAL AB Jan 8, 2019
500MG

tablet Prescription ORAL AB Jul 31, 2020





9. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A Sep 13, 2010
250MG

capsule Discontinued ORAL N/A Oct 27, 2011





10. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 3 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

for suspension Prescription ORAL AB Sep 11, 2023
250MG

capsule Prescription ORAL AB Oct 22, 2024
500MG

tablet Prescription ORAL AB Oct 22, 2024





11. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB Jul 29, 2008
250MG

capsule Prescription ORAL AB Jul 29, 2008


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





12. JUBILANT CADISTA

Jubilant Cadista Pharmaceuticals Inc has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Jubilant Cadista.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A Dec 15, 2014
250MG

capsule Discontinued ORAL N/A Dec 15, 2014


Manufacturing Plant Locations
New

Jubilant Cadista's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Jubilant Cadista as present at those locations.

Country City Firm Name
United States
Salisbury Jubilant Cadista Pharmaceuticals, Inc.





13. LANNETT CO INC

Lannett Co Inc has filed for 1 generic for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

for suspension Prescription ORAL AB Jul 29, 2021





14. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Prescription ORAL AB May 4, 2009
500MG

tablet Prescription ORAL AB May 4, 2009


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Saint Albans Mylan Technologies, Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
India
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





15. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Prescription ORAL AB Oct 15, 2008
500MG

tablet Prescription ORAL AB Oct 15, 2008


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





16. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Prescription ORAL AB Jun 10, 2010
500MG

tablet Prescription ORAL AB Jun 10, 2010
200MG/ML

for suspension Prescription ORAL AB Aug 29, 2023


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





17. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A May 4, 2009
250MG

capsule Prescription ORAL AB May 6, 2009





18. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

for suspension Prescription ORAL AB Jan 25, 2022





19. VISTAPHARM

Vistapharm Inc has filed for 1 generic for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Vistapharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

for suspension Prescription ORAL AB Feb 12, 2019





20. ZHEJIANG HISUN PHARM

Zhejiang Hisun Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Zhejiang Hisun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Prescription ORAL AB Nov 13, 2017
500MG

tablet Prescription ORAL AB Nov 16, 2017


Manufacturing Plant Locations
New

Zhejiang Hisun Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Zhejiang Hisun Pharm as present at those locations.

Country City Firm Name
China
Taizhou Zhejiang Hisun Pharmaceutical Co., Ltd.





21. ZYDUS PHARMS USA INC

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Mycophenolate Mofetil. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A May 4, 2009
250MG

capsule Discontinued ORAL N/A May 4, 2009