Glatiramer acetate - Generic Drug Details

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What are the generic drug 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

See drug prices for glatiramer acetate

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	N/A

See all glatiramer acetate clinical trials

Medical Subject Heading (MeSH) Categories for glatiramer acetate

Adjuvants, Immunologic
Antirheumatic Agents
Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for glatiramer acetate

L03AX	Other immunostimulants
L03A	IMMUNOSTIMULANTS
L03	IMMUNOSTIMULANTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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	⤷ 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
Sandoz	GLATOPA	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	090218-001	Apr 16, 2015	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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	020622-003	Jan 28, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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