Glatiramer acetate - Generic Drug Details

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
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
Mylan	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	206936-001	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
Sandoz	GLATOPA	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	206921-001	Feb 12, 2018	AP	RX	No	No
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-003	Jan 28, 2014	AP	RX	Yes	Yes

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
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	FOR SOLUTION;SUBCUTANEOUS	020622-001	Dec 20, 1996

Glatiramer acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glatiramer Acetate

Introduction

Glatiramer acetate, a disease-modifying therapy for relapsing-remitting multiple sclerosis (MS), has been a significant player in the pharmaceutical market. The introduction of generic versions and changes in market exclusivity have dramatically impacted its market dynamics and financial trajectory.

Market Exclusivity and Generic Competition

The market exclusivity for daily injections of glatiramer acetate expired in 2015, but the manufacturer's strategic launch of a 3-times-weekly version in 2014 delayed full generic competition until late 2017. This delay had substantial financial implications[2][4][5].

Impact of Generic Competition

When generic competition began for the daily formulation in 2015, it did not significantly reduce spending. However, once generic competition extended to the 3-times-weekly version in 2017, prices dropped by 47% to 64%, and spending decreased to $508 million per quarter by 2019. This reduction in spending was statistically significant (P < .001 for slope)[2][4][5].

Excess Spending Due to Delayed Generic Competition

The 2.5-year delay in full generic competition resulted in estimated excess spending of $4.3 billion to $6.5 billion. This excess spending highlights the financial burden imposed by extended market exclusivity for brand-name drugs[2][4][5].

Utilization Trends Among Insurer Types

The adoption of generic glatiramer acetate varies among different insurer types. Medicare observed the greatest decline in branded glatiramer acetate use (70%) and the second-highest generic utilization uptake (28% share). Commercial insurers saw the greatest claim volume and significant generic growth (26% share), while Medicaid had the lowest utilization volume but the highest ratio of generic utilization (45%)[1].

Patient Out-of-Pocket Costs

Generic glatiramer acetate offers significant savings for patients. Across all payment types, generics provided approximately a 20% discount in patient out-of-pocket costs compared to branded versions. Medicaid patients had the lowest out-of-pocket costs, while those using branded versions had the highest[1].

Market Size and Growth Projections

The global glatiramer acetate market is expected to grow, with estimates spanning from 2019 to 2031. The market size and compound annual growth rate (CAGR) are forecasted to provide insights into future trends and growth opportunities. The market is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America[3].

Regional Analysis

The regional analysis of the glatiramer acetate market provides a detailed understanding of revenue share, current trends, and growth rates. This segmentation helps in identifying key contributing countries and regions, which is crucial for market strategy and investment decisions[3].

Application and End-Use Analysis

Glatiramer acetate is primarily used for treating relapsing-remitting multiple sclerosis. The demand analysis across different end-use industries helps in understanding the market's driving factors and fastest-growing segments. This includes assessing factors such as profit, product price, capacity, production, and supply-demand dynamics[3].

Financial Trajectory

From 2011 to 2015, US glatiramer spending increased to $962 million per quarter. Despite generic competition for the daily formulation from 2015 to 2017, spending remained high. However, with full generic competition for both daily and 3-times-weekly versions starting in 2017, spending decreased substantially to $508 million per quarter by 2019[2][4][5].

Quarterly Spending Trends

• Before Generic Competition (2011-2015): Spending increased to $962 million per quarter.
• During Generic Competition for Daily Glatiramer (2015-2017): Spending remained just below $1 billion per quarter.
• During Generic Competition for Both Daily and 3-Times-Weekly Glatiramer (2017-2019): Spending decreased to $508 million per quarter[2][4].

Policy Implications

The findings suggest that policy makers should implement policies to prevent manufacturers from delaying generic competition by introducing new versions of existing drugs. Encouraging incremental innovations at a lower societal cost could be more beneficial[2][4][5].

Quote from Industry Experts

"Extended market exclusivity from introducing a new version of an existing brand-name drug can yield manufacturer returns out of proportion to the level of investment or risk involved; more limited incentives could encourage incremental innovations to existing drugs at a lower societal cost," as noted in a study published in JAMA Internal Medicine[2].

Illustrative Statistics

• Generic Market Share: Generic glatiramer acetate claims grew by 155% over 16 months, reaching approximately 30% of the market share[1].
• Price Reduction: Prices decreased by 47% to 64% after generic competition began for the 3-times-weekly version[2][4][5].
• Excess Spending: The delay in generic competition resulted in $4.3 billion to $6.5 billion in excess spending from 2015 to 2019[2][4][5].

Conclusion

The market dynamics and financial trajectory of glatiramer acetate have been significantly influenced by the introduction of generic versions and changes in market exclusivity. The delayed entry of generics led to substantial excess spending, highlighting the need for policies that promote timely generic competition and reduce healthcare costs.

Key Takeaways

• Generic competition for glatiramer acetate led to significant price reductions and spending decreases.
• Delayed generic competition resulted in billions of dollars in excess spending.
• Different insurer types have varying rates of generic uptake.
• Patient out-of-pocket costs are lower with generic versions.
• The global market for glatiramer acetate is expected to grow, with regional variations in demand and growth rates.

FAQs

Q: What was the impact of generic competition on the prices of glatiramer acetate?

A: After generic competition began for the 3-times-weekly version in 2017, prices decreased by 47% to 64%, leading to a significant reduction in spending[2][4][5].

Q: How did the introduction of a 3-times-weekly version of glatiramer acetate affect market dynamics?

A: The introduction of the 3-times-weekly version delayed full generic competition until 2017, sustaining brand-name dominance and resulting in excess spending of $4.3 billion to $6.5 billion[2][4][5].

Q: What are the differences in generic uptake among different insurer types?

A: Medicare saw the greatest decline in branded use and the second-highest generic uptake, while commercial insurers had the greatest claim volume and significant generic growth. Medicaid had the lowest utilization volume but the highest ratio of generic use[1].

Q: How do patient out-of-pocket costs compare between branded and generic glatiramer acetate?

A: Generic glatiramer acetate offers approximately a 20% discount in patient out-of-pocket costs compared to branded versions, with Medicaid patients having the lowest out-of-pocket costs[1].

Q: What are the projected growth trends for the global glatiramer acetate market?

A: The global market is expected to grow from 2019 to 2031, with forecasts providing insights into regional and country-level trends, revenue share, and growth rates[3].

Sources

1. Prescription Trends in Branded Versus Generic Glatiramer Acetate - Medica Musc Research Commons.
2. US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer - JAMA Internal Medicine.
3. Glatiramer Acetate Market Report 2024 (Global Edition) - Cognitive Market Research.
4. US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer - PubMed.
5. Delayed Generic Competition for MS Drug Cost Billions - Physicians Weekly.