DrugPatentWatch Database Preview
TREXIMET Drug Profile
When do Treximet patents expire, and what generic alternatives are available?
Treximet is a drug marketed by Pernix Ireland Ltd 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. Seven 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: | 3 |
| 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 |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for TREXIMET |
| DailyMed Link: | TREXIMET at DailyMed |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 TREXIMET
Paragraph IV (Patent) Challenges for TREXIMET
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 500 mg/85 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for TREXIMET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1575566 | ➤ Sign Up |
| Japan | 4616009 | ➤ Sign Up |
| European Patent Office | 1575566 | ➤ Sign Up |
| Japan | 2006515856 | ➤ Sign Up |
| Spain | 2380827 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004060355 | ➤ Sign Up |
| Austria | 546134 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for TREXIMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | 122012000051 | Germany | ➤ Sign Up | 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 | SPC/GB11/013 | United Kingdom | ➤ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 0984957 | CR 2012 00035 | Denmark | ➤ Sign Up | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105 |
| 1411900 | 122012000052 | Germany | ➤ Sign Up | PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105 |
| 0984957 | PA2011005 | Lithuania | ➤ Sign Up | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| 1411900 | SPC/GB11/015 | United Kingdom | ➤ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1411900 | 1190013-1 | Sweden | ➤ Sign Up | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
