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Colchicine Patent Expiration

Colchicine is Used for treating and reducing the risk of cardiovascular events, acute myocardial infarction, atherosclerotic vascular disease, and inflammation. It was first introduced by Takeda Pharmaceuticals Usa Inc in its drug Colcrys on Jul 29, 2009. Other drugs containing Colchicine are Mitigare, Gloperba, Lodoco. 16 different companies have introduced drugs containing Colchicine.


Colchicine Patents

Given below is the list of patents protecting Colchicine, 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
Gloperba US10226423 Colchicine drug-to-drug interactions Dec 20, 2037 Scilex Pharms
Gloperba US10383820 Colchicine drug-to-drug interactions Nov 22, 2036 Scilex Pharms
Gloperba US10383821 Colchicine drug-to-drug interactions Nov 22, 2036 Scilex Pharms
Gloperba US9907751 Composition and method of use of colchicine oral liquid Nov 22, 2036 Scilex Pharms
Lodoco US10130585 Methods of treating and/or preventing cardiovascular disease May 09, 2034 Agepha Pharma Fz
Lodoco US10206891 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Nov 01, 2033 Agepha Pharma Fz
Lodoco US10265281 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Nov 01, 2033 Agepha Pharma Fz
Lodoco US10842762 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Nov 01, 2033 Agepha Pharma Fz
Lodoco US11026899 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Nov 01, 2033 Agepha Pharma Fz
Lodoco US11026900 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Nov 01, 2033 Agepha Pharma Fz
Lodoco US11026901 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Nov 01, 2033 Agepha Pharma Fz
Lodoco US11944594 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Nov 01, 2033 Agepha Pharma Fz
Lodoco US11944595 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Nov 01, 2033 Agepha Pharma Fz
Lodoco US9744144 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Nov 01, 2033 Agepha Pharma Fz
Mitigare US8927607 Methods of colchicine administration Aug 22, 2033 Hikma Intl Pharms
Mitigare US9399036 Methods of colchicine administration Aug 22, 2033 Hikma Intl Pharms
Mitigare US9555029 Methods of colchicine administration Aug 22, 2033 Hikma Intl Pharms
Mitigare US9675613 Methods of colchicine administration Aug 22, 2033 Hikma Intl Pharms
Mitigare US9789108 Methods of colchicine administration Aug 22, 2033 Hikma Intl Pharms
Colcrys US7820681 Methods for concomitant administration of colchicine and a second active agent Feb 17, 2029 Takeda Pharms Usa
Colcrys US7906519 Methods for concomitant administration of colchicine and a second active agent Feb 17, 2029 Takeda Pharms Usa
Colcrys US7915269 Methods for concomitant administration of colchicine and a second active agent Feb 17, 2029 Takeda Pharms Usa
Colcrys US8440721 Methods for concomitant administration of colchicine and a second active agent Feb 17, 2029 Takeda Pharms Usa
Colcrys US8440722 Methods for concomitant administration of colchicine and a second active agent Feb 17, 2029 Takeda Pharms Usa
Colcrys US7601758 Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares Feb 10, 2029 Takeda Pharms Usa
Colcrys US7619004 Methods for concomitant administration of colchicine and macrolide antibiotics Dec 03, 2028 Takeda Pharms Usa
Colcrys US7935731 Methods for concomitant administration of colchicine and macrolide antibiotics Dec 03, 2028 Takeda Pharms Usa
Colcrys US7964647 Colchicine compositions and methods Oct 06, 2028 Takeda Pharms Usa
Colcrys US7964648 Methods for concomitant administration of colchicine and a second active agent Oct 06, 2028 Takeda Pharms Usa
Colcrys US7981938 Colchicine compositions and methods Oct 06, 2028 Takeda Pharms Usa
Colcrys US8093296 Methods for concomitant administration of colchicine and macrolide antibiotics Oct 06, 2028 Takeda Pharms Usa
Colcrys US8093297 Methods for concomitant administration of colchicine and a second active agent Oct 06, 2028 Takeda Pharms Usa
Colcrys US8093298 Methods for concomitant administration of colchicine and macrolide antibiotics Oct 06, 2028 Takeda Pharms Usa
Colcrys US8097655 Methods for concomitant administration of colchicine and macrolide antibiotics Oct 06, 2028 Takeda Pharms Usa
Colcrys US8415395 Colchicine compositions and methods Oct 06, 2028 Takeda Pharms Usa
Colcrys US8415396 Colchine compositions and methods Oct 06, 2028 Takeda Pharms Usa



Colchicine's Family Patents

Family Patents

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Colchicine Generic API Manufacturers

Several generic applications have been filed for Colchicine. The first generic version for Colchicine was by Amneal Pharmaceuticals and was approved on Sep 28, 2016. And the latest generic version is by Granules Pharmaceuticals Inc and was approved on Apr 29, 2024.

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


1. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Colchicine. 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
0.6MG

tablet Prescription ORAL AB Feb 8, 2019





2. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Colchicine. 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
0.6MG

tablet Prescription ORAL AB Sep 28, 2016





3. ANNORA PHARMA

Annora Pharma Private Ltd has filed for 1 generic for Colchicine. Given below are the details of the strengths of this generic introduced by Annora Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.6MG

capsule Prescription ORAL AB Apr 29, 2024


Manufacturing Plant Locations
New

Annora 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 Annora Pharma as present at those locations.

Country City Firm Name
India
Hyderabad Annora Pharma Private Limited





4. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Colchicine. 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
0.6MG

capsule Prescription ORAL AB Apr 29, 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





5. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Colchicine. 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
0.6MG

tablet Prescription ORAL AB Sep 6, 2019





6. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Colchicine. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.6MG

(reference standard)

tablet Prescription ORAL AB Aug 12, 2021





7. GRANULES

Granules Pharmaceuticals Inc has filed for 1 generic for Colchicine. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.6MG

capsule Prescription ORAL AB Apr 29, 2024


Manufacturing Plant Locations
New

Granules'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 Granules as present at those locations.

Country City Firm Name
United States
Chantilly Granules Pharmaceuticals Inc.
Manassas Granules Consumer Health Inc.
India
Parawada Mandal Granules India Limited
Sangareddy District Granules India Limited
Visakhapatnam Granules India Limited
Medchal-Malkhajgiri District Granules India Limited
Secunderabad Granules India Limited





8. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 1 generic for Colchicine. 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
0.6MG

tablet Prescription ORAL AB Aug 13, 2021





9. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Colchicine. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.6MG

tablet Discontinued ORAL N/A Sep 16, 2019


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





10. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Colchicine. 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
0.6MG

tablet Prescription ORAL AB Mar 10, 2022


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





11. WATSON LABS INC

Watson Laboratories Inc has filed for 1 generic for Colchicine. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.6MG

tablet Prescription ORAL AB Jul 31, 2019





12. ZYDUS PHARMS

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.6MG

tablet Prescription ORAL AB Feb 19, 2019
0.3MG

tablet Prescription ORAL N/A Nov 14, 2019