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Last Updated: December 25, 2024

copaxone Drug Patent Profile


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Which patents cover Copaxone, 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 3rd, 2017.

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Drug patent expirations by year for copaxone
Drug Prices for copaxone

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Drug Sales Revenue Trends for copaxone

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Recent Clinical Trials for copaxone

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

SponsorPhase
University of Kansas Medical CenterPhase 1
Genzyme, a Sanofi CompanyPhase 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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 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 ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for copaxone

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

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

Supplementary Protection Certificates for copaxone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0762888 C300251 Netherlands ⤷  Subscribe 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 ⤷  Subscribe 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 ⤷  Subscribe
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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