GLATIRAMER ACETATE - Generic Drug Details
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What are the generic sources for glatiramer acetate and what is the scope of patent protection?
Glatiramer acetate
is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Mylan, Synthon Pharms Inc, and Sandoz, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for glatiramer acetate. Four suppliers are listed for this compound.
Summary for GLATIRAMER ACETATE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 4 |
| NDAs: | 7 |
| Drug Master File Entries: | 4 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Clinical Trials: | 81 |
| Patent Applications: | 7,171 |
| Drug Prices: | Drug price trends for GLATIRAMER ACETATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLATIRAMER ACETATE |
| What excipients (inactive ingredients) are in GLATIRAMER ACETATE? | GLATIRAMER ACETATE excipients list |
| DailyMed Link: | GLATIRAMER ACETATE at DailyMed |
Recent Clinical Trials for GLATIRAMER ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Phase 2/Phase 3 |
| Institut National de la Santé Et de la Recherche Médicale, France | Phase 2/Phase 3 |
| National Cheng-Kung University Hospital | N/A |
Medical Subject Heading (MeSH) Categories for GLATIRAMER ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for GLATIRAMER ACETATE
Paragraph IV (Patent) Challenges for GLATIRAMER ACETATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| COPAXONE | Injection | glatiramer acetate | 40 mg/mL, 1 mL pre- filled syringe | 020622 | 2 | 2014-02-26 |
| COPAXONE | Injection | glatiramer acetate | 20 mg/mL, 1mL pre- filled syringe | 020622 | 1 | 2007-12-27 |
US Patents and Regulatory Information for GLATIRAMER ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-002 | Feb 12, 2002 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-003 | Jan 28, 2014 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Synthon Pharms Inc | GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 203857-001 | Sep 25, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 091646-001 | Oct 3, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Synthon Pharms Inc | GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 206873-001 | Sep 25, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | COPAXONE | glatiramer acetate | FOR SOLUTION;SUBCUTANEOUS | 020622-001 | Dec 20, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 206936-001 | Oct 3, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GLATIRAMER ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-002 | Feb 12, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-003 | Jan 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | FOR SOLUTION;SUBCUTANEOUS | 020622-001 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-002 | Feb 12, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-003 | Jan 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-002 | Feb 12, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-002 | Feb 12, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
