COPAXONE Drug Patent Profile
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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 3rd, 2017.
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Questions you can ask:
- What is the 5 year forecast for COPAXONE?
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- What is Average Wholesale Price for COPAXONE?
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 |
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 |
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 | ⤷ 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 COPAXONE
| 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 |
| >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 |
|---|---|---|---|
| Spain | 2424692 | ⤷ Sign Up | |
| Portugal | 762888 | ⤷ Sign Up | |
| European Patent Office | 3199172 | REGIME POSOLOGIQUE POUR LA SCLEROSE EN PLAQUES (DOSING REGIMEN FOR MULTIPLE SCLEROSIS) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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