Glatiramer acetate - Generic Drug Details
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What are the generic drug sources for glatiramer acetate and what is the scope of freedom to operate?
Glatiramer acetate
is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Mylan, and Sandoz, and is included in five 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: | 3 |
NDAs: | 5 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 81 |
Patent Applications: | 7,407 |
Formulation / Manufacturing: | see details |
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 |
---|---|
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | GLATOPA | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 206921-001 | Feb 12, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-002 | Feb 12, 2002 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 091646-001 | Oct 3, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | COPAXONE | glatiramer acetate | FOR SOLUTION;SUBCUTANEOUS | 020622-001 | Dec 20, 1996 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan | GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 206936-001 | Oct 3, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | GLATOPA | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 090218-001 | Apr 16, 2015 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-003 | Jan 28, 2014 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |