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Generated: August 20, 2017
What is the patent landscape for Treximet, and what generic Treximet alternatives are available?
Treximet is a drug marketed by Pernix Ireland Ltd and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 3 |
| Clinical Trials: see list | 22 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | TREXIMET at DailyMed |
| 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 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| naproxen sodium and sumatriptan succinate | Tablets | 500 mg/85 mg | Treximet (Correction) | 7/23/2008 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2003303631 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2000506541 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 169041 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2005325143 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2509023 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB11/013 | United Kingdom | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 | ||||||||||||||||||||||||||
| 00481 | Netherlands | ► Subscribe | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 | ||||||||||||||||||||||||||
| 2012 00035 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 11/016 | Ireland | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 | ||||||||||||||||||||||||||
| C/GB11/015 | United Kingdom | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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