GLATIRAMER ACETATE - Generic Drug Details

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, Chemi Spa, Hybio, Mylan, Scinopharm Taiwan, Synthon Pharms Inc, and Sandoz, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for glatiramer acetate. Nine suppliers are listed for this compound.

Summary for GLATIRAMER ACETATE

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	11
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	81
Patent Applications:	7,508
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
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

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

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
Teva Pharms Usa	COPAXONE	glatiramer acetate	FOR SOLUTION;SUBCUTANEOUS	020622-001	Dec 20, 1996		DISCN	Yes	No
Synthon Pharms Inc	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	206873-001	Sep 25, 2024	AP	RX	No	No
Mylan	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	206936-001	Oct 3, 2017	AP	RX	No	No
Scinopharm Taiwan	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	214741-001	Dec 31, 2025	AP	RX	No	No

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	020622-003	Jan 28, 2014
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-002	Feb 12, 2002
Teva Pharms Usa	COPAXONE	glatiramer acetate	FOR SOLUTION;SUBCUTANEOUS	020622-001	Dec 20, 1996
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-002	Feb 12, 2002
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-002	Feb 12, 2002

Market Dynamics and Financial Trajectory of Glatiramer Acetate

Last updated: February 12, 2026

Overview:
Glatiramer Acetate, branded as Copaxone by Teva Pharmaceuticals, is a leading disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). Since its approval in 1996, it has maintained a significant market position but faces increasing competition from newer oral and infusion therapies.

Market Size and Growth Trends:
The global MS treatment market was valued at approximately USD 22 billion in 2022, expected to reach USD 35 billion by 2030, with a compound annual growth rate (CAGR) of around 6%. Glatiramer Acetate accounted for roughly 25-30% of this segment in 2022, translating to USD 5.5-6.6 billion annually.

Market Share and Competition:
Glatiramer Acetate is the first-in-class MS DMT and held over 70% market share in the U.S. in 2018. Post-exclusivity expirations in key markets, new entrants like oral agents (e.g., Novartis' Gilenya, Biogen's Tecfidera) have eroded share, leading to a decline in revenue for Copaxone.

Formulation Variants and Patent Status:

• Original Formulations: Teva's branded injectable Copaxone (20 mg/mL and 40 mg/mL) had patent protections that prevented generics until around 2014.
• Generic Entry: Since 2014, multiple generic versions entered markets globally, leading to significant price erosion, especially in the U.S. and Europe.
• Modified Formulations: Teva launched a 40 mg/mL version in 2014 to extend market exclusivity, but generic competition persisted.

Pricing and Revenue Dynamics:

• In the U.S., branded Glatiramer Acetate prices ranged from USD 60,000 to USD 70,000 annually per patient pre-generic entry.
• Generics introduced discounts of up to 70%, reducing overall revenues.
• Globally, prices vary; Europe generally exhibits lower costs due to health system negotiations.

Regulatory and Patent Developments:

• Patent expirations and the introduction of biosimilars in the U.S. and Europe have contributed to revenue declines.
• Regulatory authorities continue to evaluate claims related to device combinations and new formulations, influencing market access.

Financial Performance and Future Outlook:

• Teva's MS franchise, primarily driven by Glatiramer Acetate, contributed roughly USD 3.5 billion of revenue in 2022 but declined from the USD 4-4.5 billion range in 2018.
• The company anticipates eventual stabilization post-generic erosion but notes the challenge in maintaining high margins amid pricing pressures.
• Launch of new formulations or delivery systems (e.g., self-administered injectors) could help sustain market share.

Implications for Investors and R&D:

• Market share erosion suggests reduced revenue potential unless innovation offsets generic competition.
• Ongoing R&D on combination therapies and novel oral agents represents a strategic pivot away from reliance on Glatiramer Acetate.
• Potential growth could stem from emerging markets with less mature MS treatment landscapes.

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Key Takeaways:

• Glatiramer Acetate dominated the MS market since 1996 but faces diminishing revenues due to patent expirations and generics.
• The global MS treatment market is expanding, yet the share attributable to Glatiramer Acetate is declining.
• Price competition, biosimilar entries, and evolving treatment paradigms challenge revenue stability.
• Future financial trajectories depend on pipeline innovation and market access strategies.

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FAQs

What caused the decline of Glatiramer Acetate’s market share?
Patent expirations led to generic versions, significantly reducing prices and market share, complemented by the rise of oral therapies offering comparable efficacy.

How is Teva responding to generic competition?
Teva has launched new formulations and delivery devices to extend product lifecycle, while also diversifying its MS pipeline.

Are biosimilars impacting Glatiramer Acetate?
Yes. Biosimilars and generics are reducing prices and revenues in regions where their approval and uptake are swift.

What is the outlook for Glatiramer Acetate in the next five years?
Revenues are expected to decline further unless new formulations or indications are approved. Market share stabilization may come from novel delivery systems.

Which regions present growth opportunities for the drug?
Emerging markets with increasing MS diagnosis and less aggressive price negotiations may offer growth prospects.

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References

1. Market data sourced from reports by Grand View Research and IQVIA (2022-2023).
2. Patent and regulatory updates from U.S. FDA and European Medicines Agency (2022-2023).
3. Teva financial disclosures and earnings calls (2022-2023).