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TREXIMET Drug Profile
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» See Plans and PricingWhen do Treximet patents expire, and when can generic versions of Treximet launch?
Treximet is a drug marketed by Currax and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has sixteen patent family members in fourteen countries.
The generic ingredient in TREXIMET is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.
US ANDA Litigation and Generic Entry Outlook for Treximet
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for TREXIMET
| International Patents: | 16 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 22 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TREXIMET |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TREXIMET |
| DailyMed Link: | TREXIMET at DailyMed |
Recent Clinical Trials for TREXIMET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dent Neurologic Institute | N/A |
| Premiere Research Institute | Phase 2/Phase 3 |
| GlaxoSmithKline | Phase 2/Phase 3 |
Recent Litigation for TREXIMET
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD. | 2011-07-20 |
| Pozen Inc. v. Sun Pharma Global FZE | 2011-05-26 |
| Pozen Inc. v. Teva Pharmaceuticals USA Inc. | 2009-04-24 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2015-11-12 |
Synonyms for TREXIMET
| 811794-26-0 |
| Naproxen / sumatriptan |
| Naproxen mixture with sumatriptan |
| Naproxen sodium mixture with sumatriptan succinate |
| Sumatriptan mixture with naproxen |
| Sumatriptan succinate and naproxen sodium |
| Sumatriptan succinate mixture with naproxen sodium |
| Trexima |
Paragraph IV (Patent) Challenges for TREXIMET
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TREXIMET | TABLET;ORAL | naproxen sodium; sumatriptan succinate | 021926 | 2008-07-23 |
US Patents and Regulatory Information for TREXIMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >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 TREXIMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | Start Trial | Start Trial |
| Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | Start Trial | Start Trial |
| Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TREXIMET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Finland | 852969 | Start Trial |
| Spain | 545810 | Start Trial |
| Spain | 2380827 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TREXIMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | 18/2011 | Austria | Start Trial | PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105 |
| 0984957 | 122012000051 | Germany | Start Trial | PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105 |
| 0984957 | PA2011005 | Lithuania | Start Trial | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
