GLATIRAMER ACETATE Drug Patent Profile
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Which patents cover Glatiramer Acetate, and what generic alternatives are available?
Glatiramer Acetate is a drug marketed by Mylan and Synthon Pharms Inc and is included in four NDAs.
The generic ingredient in GLATIRAMER ACETATE is glatiramer acetate. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Glatiramer Acetate
A generic version of GLATIRAMER ACETATE was approved as glatiramer acetate by MYLAN on October 3rd, 2017.
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Summary for GLATIRAMER ACETATE
Recent Clinical Trials for GLATIRAMER ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | Phase 2/Phase 3 |
| Assistance Publique - Hôpitaux de Paris | Phase 2/Phase 3 |
| Ministry of Science and Technology, Taiwan | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Mylan | GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 206936-001 | Oct 3, 2017 | AP | RX | No | No | ⤷ 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
