COPAXONE Drug Patent Profile

When do Copaxone patents expire, and when can generic versions of Copaxone launch?

Copaxone is a drug marketed by Teva Pharms Usa and is included in one NDA.

The generic ingredient in COPAXONE 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 Copaxone

A generic version of COPAXONE was approved as glatiramer acetate by MYLAN on October 3^rd, 2017.

Summary for COPAXONE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	52
Drug Prices:	Drug price information for COPAXONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COPAXONE
What excipients (inactive ingredients) are in COPAXONE?	COPAXONE excipients list
DailyMed Link:	COPAXONE at DailyMed

See drug prices for COPAXONE

See drug sales revenues for COPAXONE

Recent Clinical Trials for COPAXONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Kansas Medical Center	Phase 1
Genzyme, a Sanofi Company	Phase 3
Teva Pharmaceutical Industries, Ltd.	Phase 4

See all COPAXONE clinical trials

Paragraph IV (Patent) Challenges for COPAXONE

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 COPAXONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	COPAXONE	glatiramer acetate	FOR SOLUTION;SUBCUTANEOUS	020622-001	Dec 20, 1996		DISCN	Yes	No
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-002	Feb 12, 2002	AP	RX	Yes	Yes
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-003	Jan 28, 2014	AP	RX	Yes	Yes

Expired US Patents for COPAXONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms Usa	COPAXONE	glatiramer acetate	FOR SOLUTION;SUBCUTANEOUS	020622-001	Dec 20, 1996
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-003	Jan 28, 2014
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-003	Jan 28, 2014
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
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-002	Feb 12, 2002

International Patents for COPAXONE

See the table below for patents covering COPAXONE around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	T75672
Moldova, Republic of	1443
China	107050423	低频醋酸格拉替雷疗法 (Low frequency glatiramer acetate therapy)
China	1152874
South Korea	20120090044	LOW FREQUENCY GLATIRAMER ACETATE THERAPY
Japan	6169644
South Korea	20140061559	MEDICAMENT COMPRISING GLATIRAMER ACETATE

Supplementary Protection Certificates for COPAXONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0762888	C300251	Netherlands		PRODUCT NAME: GLATIRAMEER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET ACETAAT; NATL. REGISTRATION NO/DATE: RVG 26748 20010927; FIRST REGISTRATION: GB PL 10921/0019 20000809
0762888	C300096	Netherlands		PRODUCT NAME: GLATIRAMEER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET ACETAAT; NAT. REGISTRATION NO/DATE: RVG 26748 20010927: FIRST REGISTRATION: GB PL 10921/0019 20000809
0762888	90987	Luxembourg

COPAXONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COPAXONE

Introduction to COPAXONE

COPAXONE, also known as glatiramer acetate, is a popular drug used in the treatment of multiple sclerosis (MS), a chronic and often disabling autoimmune disease. Developed by Teva Pharmaceutical Industries, COPAXONE has been a significant player in the MS treatment market for several years.

Historical Performance

Historically, COPAXONE has been one of the leading drugs in the MS treatment market. However, its performance has seen fluctuations in recent years.

• Revenue Trends: In the past, COPAXONE generated substantial revenues for Teva. For instance, in the early 2010s, it was one of the company's top-selling drugs. However, recent years have seen a decline in its revenue. In the fourth quarter of 2023, COPAXONE revenues in Teva's Europe segment decreased by 8% to $56 million compared to the same period in 2022[5].

Impact of Market Competition

The MS treatment market has become increasingly competitive, which has affected COPAXONE's market share.

• Emergence of New Treatments: The introduction of new and innovative treatments, such as monoclonal antibodies (e.g., Ocrevus by F. Hoffmann-La Roche Ltd.), has shifted market dynamics. These newer drugs have gained significant traction, leading to a decline in the demand for older treatments like COPAXONE[1].
• Generic Competition: The expiration of COPAXONE's patent has allowed generic versions to enter the market, further eroding its market share. Generic competition has been a significant factor in the decline of COPAXONE's revenues[5].

Financial Performance

The financial performance of COPAXONE reflects the broader trends in the MS treatment market.

• Revenue Decline: The decline in COPAXONE revenues is evident from Teva's financial reports. For example, in 2023, the revenues from COPAXONE were lower due to increased competition and the impact of generic versions[5].
• Impact on Teva's Financials: While Teva's overall revenues increased in 2023, partly due to other products like AUSTEDO and AJOVY, the decline in COPAXONE revenues was a notable factor. The company's gross profit margin and operating income were affected by the lower revenues from COPAXONE, among other factors[5].

Market Factors Affecting COPAXONE

Several market factors have contributed to the changing financial trajectory of COPAXONE.

• COVID-19 Pandemic: The COVID-19 pandemic had a significant impact on the MS treatment market, including COPAXONE. The pandemic led to delays in diagnosis and treatment, reduced patient volumes, and reallocation of healthcare resources, all of which affected sales[1].
• Government Initiatives and Accessibility: Government initiatives to improve the accessibility of MS treatments have generally boosted the market, but this has also led to increased competition as more patients seek newer and more effective treatments[1].

Regional Performance

The performance of COPAXONE varies across different regions.

• Europe: In Europe, COPAXONE revenues have declined, partly due to the introduction of generic versions and increased competition from newer drugs[5].
• North America: While COPAXONE still generates revenue in North America, the market is highly competitive, and the drug faces significant challenges from other treatments[5].

Future Outlook

The future outlook for COPAXONE is challenging due to the ongoing market trends.

• Competition from Newer Treatments: The continued development and launch of new MS treatments, especially monoclonal antibodies, will likely further reduce COPAXONE's market share[1].
• Generic Competition: The presence of generic versions of COPAXONE will continue to erode its revenue base[5].

Key Takeaways

• Declining Revenues: COPAXONE has seen a decline in revenues due to increased competition and the impact of generic versions.
• Market Competition: The emergence of new treatments, particularly monoclonal antibodies, has significantly impacted COPAXONE's market share.
• Financial Impact: The decline in COPAXONE revenues has affected Teva's financial performance, including its gross profit margin and operating income.
• Future Challenges: COPAXONE faces ongoing challenges from newer treatments and generic competition, which will likely continue to affect its market position.

FAQs

1. What is COPAXONE used for?

   • COPAXONE (glatiramer acetate) is used in the treatment of multiple sclerosis (MS), a chronic autoimmune disease.

2. Why has COPAXONE's revenue declined?

   • COPAXONE's revenue has declined due to increased competition from newer treatments, the introduction of generic versions, and the impact of the COVID-19 pandemic.

3. What are some of the new treatments affecting COPAXONE's market share?

   • Newer treatments such as monoclonal antibodies (e.g., Ocrevus by F. Hoffmann-La Roche Ltd.) have significantly impacted COPAXONE's market share.

4. How has the COVID-19 pandemic affected COPAXONE sales?

   • The COVID-19 pandemic led to delays in diagnosis and treatment, reduced patient volumes, and reallocation of healthcare resources, all of which affected COPAXONE sales.

5. What is the future outlook for COPAXONE?

   • The future outlook for COPAXONE is challenging due to ongoing competition from newer treatments and generic versions, which will likely continue to erode its market share.

Sources

1. Fortune Business Insights: Multiple Sclerosis Drugs Market | Competitive Landscape [2032]
2. Teva Pharmaceutical Industries: TEVA REPORTS GROWTH IN FOURTH QUARTER AND FULL YEAR 2023
3. SkyQuestT: Multiple Sclerosis Drugs Market Analysis, Size, Share & Trends | 2031
4. GlobeNewswire: Multiple Sclerosis Drugs Market Outlook and Strategic Business Report 2024-2030
5. Teva Pharmaceutical Industries: Teva Reports Growth in Fourth Quarter and Full Year 2023