DrugPatentWatch Database Preview
TREXIMET Drug Profile
When do Treximet patents expire, and what generic alternatives are available?
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. Six suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.
Summary for TREXIMET
| International Patents: | 16 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| 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 |
| GlaxoSmithKline | Phase 2/Phase 3 |
| Premiere Research Institute | 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 |
|---|---|
| Graybar Pharmaceuticals, LLC | 2015-11-12 |
Pharmacology for TREXIMET
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 |
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 | 021926-001 | Apr 15, 2008 | Start Trial | Start Trial |
| Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | Start Trial | Start Trial |
| 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 | 021926-001 | Apr 15, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for TREXIMET
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 500 mg/85 mg | ➤ Subscribe | Start Trial |
International Patents for TREXIMET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2006515856 | Start Trial |
| Portugal | 1575566 | Start Trial |
| Australia | 2003303631 | Start Trial |
| Denmark | 1575566 | Start Trial |
| Cyprus | 1112640 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TREXIMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | 1190013-1 | Sweden | Start Trial | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
| 1411900 | C300481 | Netherlands | Start Trial | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 |
| 0984957 | PA2011005,C0984957 | Lithuania | Start Trial | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| 1411900 | C01411900/01 | Switzerland | Start Trial | PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011 |
| 0984957 | SPC/GB11/013 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
