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Capecitabine Patent Expiration

Capecitabine is Used for treating tumors. It was first introduced by Cheplapharm Arzneimittel Gmbh in its drug Xeloda on Apr 30, 1998. 15 different companies have introduced drugs containing Capecitabine.


Capecitabine Patents

Given below is the list of patents protecting Capecitabine, 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
Xeloda US5472949

(Pediatric)

 N4 -(substituted-oxycarbonyl)-5'-deoxy-5-fluorocytidine compounds, compositions and methods of using same Jun 14, 2014

(Expired)

 Cheplapharm
Xeloda US5472949 N4 -(substituted-oxycarbonyl)-5'-deoxy-5-fluorocytidine compounds, compositions and methods of using same Dec 14, 2013

(Expired)

 Cheplapharm



Capecitabine's Family Patents

Family Patents

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Capecitabine Generic API Manufacturers

Several generic applications have been filed for Capecitabine. The first generic version for Capecitabine was by Teva Pharmaceuticals Usa Inc and was approved on Sep 16, 2013. And the latest generic version is by Hetero Labs Ltd Unit V and was approved on Mar 5, 2024.

Given below is the list of companies who have filed for Capecitabine 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 Capecitabine. 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
150MG

tablet Prescription ORAL AB Apr 23, 2015
500MG

tablet Prescription ORAL AB Apr 23, 2015





2. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Capecitabine. 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
150MG

tablet Prescription ORAL AB Nov 24, 2017
500MG

tablet Prescription ORAL AB Nov 24, 2017





3. AMNEAL PHARMS

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

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

tablet Discontinued ORAL N/A Feb 28, 2017
150MG

tablet Discontinued ORAL N/A Feb 28, 2017





4. DR REDDYS

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

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

tablet Prescription ORAL AB Dec 4, 2020
150MG

tablet Prescription ORAL AB Dec 4, 2020





5. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Capecitabine. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

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

tablet Prescription ORAL AB Apr 17, 2018
150MG

tablet Prescription ORAL AB Apr 17, 2018


Manufacturing Plant Locations
New

Eugia Pharma'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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





6. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Capecitabine. 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
150MG

tablet Prescription ORAL AB Mar 5, 2024
500MG

tablet Prescription ORAL AB Mar 5, 2024





7. HIKMA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG

tablet Discontinued ORAL N/A Jul 14, 2016
500MG

tablet Discontinued ORAL N/A Jul 14, 2016


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





8. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Capecitabine. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG

tablet Prescription ORAL AB Jul 2, 2018
500MG

tablet Prescription ORAL AB Jul 2, 2018


Manufacturing Plant Locations
New

Msn'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 Msn as present at those locations.

Country City Firm Name
India
Kamareddy MSN Life Sciences Private Limited
Yadadri Bhuvanagiri District MSN Organics Private Limited
Rangareddy District MSN Laboratories Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Sangareddy MSN Pharmachem Private Limited
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Isnapur MSN Laboratories Private Limited, Unit-II
Sangareddy MSN Laboratories Private Ltd.
Sangareddy MSN Laboratories Private Limited, R&D Center
United States
Piscataway MSN PHARMACEUTICALS INC





9. RELIANCE LIFE

Reliance Life Sciences Pvt Ltd has filed for 2 different strengths of generic version for Capecitabine. Given below are the details of the strengths of this generic introduced by Reliance Life.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG

tablet Prescription ORAL AB Apr 27, 2020
500MG

tablet Prescription ORAL AB Apr 27, 2020


Manufacturing Plant Locations
New

Reliance Life'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 Reliance Life as present at those locations.

Country City Firm Name
India
Navi Mumbai Reliance Life Sciences Private Limited





10. RISING

Rising Pharma Holding Inc has filed for 2 different strengths of generic version for Capecitabine. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG

tablet Prescription ORAL AB Aug 8, 2014
500MG

tablet Prescription ORAL AB Aug 8, 2014


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Livingston Risingsun Iodine Products Corp.
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
East Brunswick Rising Pharma Holding, Inc.
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Phoenix Rising Sun Farms Inc
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





11. SHILPA

Shilpa Medicare Ltd has filed for 2 different strengths of generic version for Capecitabine. Given below are the details of the strengths of this generic introduced by Shilpa.

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

tablet Prescription ORAL AB Dec 12, 2016
150MG

tablet Prescription ORAL AB Dec 12, 2016


Manufacturing Plant Locations
New

Shilpa'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 Shilpa as present at those locations.

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Hyderbad Shilpa Medicare Limited
Hyderabad Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited
Bengaluru Shilpa Medicare Limited





12. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Capecitabine. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG

tablet Discontinued ORAL N/A Jun 21, 2019
500MG

tablet Discontinued ORAL N/A Jun 21, 2019


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
India
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Halol Sun Pharmaceutical Industries Ltd.
Punjab Sun Pharmaceutical Industries, Inc.
Vadodara Sun Pharmaceutical Industries Ltd.
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
New Delhi Sun Pharmaceutical Industries Limited
Mohali Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Bharuch Sun Pharmaceutical Industries Ltd
Dadra Sun Pharmaceutical Industries Limited
Ahmednagar Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.





13. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Capecitabine. 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
150MG

tablet Prescription ORAL AB Sep 16, 2013
500MG

tablet Prescription ORAL AB Sep 16, 2013





14. TEYRO LABS

Teyro Labs Private Ltd has filed for 2 different strengths of generic version for Capecitabine. Given below are the details of the strengths of this generic introduced by Teyro Labs.

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

tablet Prescription ORAL BX Oct 23, 2023
150MG

tablet Prescription ORAL BX Oct 23, 2023