Glatiramer Acetate Patent Expiration

Glatiramer Acetate is Used for treating multiple sclerosis. It was first introduced by Teva Pharmaceuticals Usa in its drug Copaxone on Dec 20, 1996. 4 different companies have introduced drugs containing Glatiramer Acetate.


Glatiramer Acetate Patents

Given below is the list of patents protecting Glatiramer Acetate, 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
Copaxone US8232250 Low frequency glatiramer acetate therapy Aug 19, 2030 Teva Pharms Usa
Copaxone US8399413 Low frequency glatiramer acetate therapy Aug 19, 2030 Teva Pharms Usa
Copaxone US8969302 Low frequency glatiramer acetate therapy Aug 19, 2030 Teva Pharms Usa
Copaxone US9155776 Low frequency glatiramer acetate therapy Aug 19, 2030 Teva Pharms Usa
Copaxone US9402874 Low frequency glatiramer acetate therapy Aug 19, 2030 Teva Pharms Usa
Copaxone US5981589 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US6054430 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US6054430 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US6342476 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US6362161 Copolymer-1 improvements on compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US6362161 Copolymer-1 improvements on compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US6620847 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US6939539 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US7199098 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US7199098 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US8367605 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa
Copaxone US8367605 Copolymer-1 improvements in compositions of copolymers May 24, 2014

(Expired)

Teva Pharms Usa



Glatiramer Acetate's Family Patents

Family Patents

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Glatiramer Acetate Generic API Manufacturers

Several generic applications have been filed for Glatiramer Acetate. The first generic version for Glatiramer Acetate was by Sandoz Inc and was approved on Apr 16, 2015. And the latest generic version is by Synthon Pharmaceuticals Inc and was approved on Sep 25, 2024.

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


1. MYLAN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML

injectable Prescription SUBCUTANEOUS AP Oct 3, 2017
20MG/ML

injectable Prescription SUBCUTANEOUS AP Oct 3, 2017


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





2. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Glatiramer Acetate. All of these versions come by the name GLATOPA. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML

injectable Prescription SUBCUTANEOUS AP Apr 16, 2015
40MG/ML

injectable Prescription SUBCUTANEOUS AP Feb 12, 2018


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
Langkampfen Sandoz GmbH
Kundl 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





3. SYNTHON PHARMS INC

Synthon Pharmaceuticals Inc has filed for 2 different strengths of generic version for Glatiramer Acetate. Given below are the details of the strengths of this generic introduced by Synthon Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML

injectable Prescription SUBCUTANEOUS AP Sep 25, 2024
20MG/ML

injectable Prescription SUBCUTANEOUS AP Sep 25, 2024





Glatiramer Acetate News

Teva, a pharmaceutical company, fined by European Commission for misuse of patents related to multiple sclerosis drug

31 Oct, 2024

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