TREXIMET Drug Patent Profile
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When 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. Five suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.
DrugPatentWatch® Generic Entry Outlook for Treximet
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for TREXIMET
International Patents: | 16 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (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 |
What excipients (inactive ingredients) are in TREXIMET? | TREXIMET excipients list |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for TREXIMET
Paragraph IV (Patent) Challenges for TREXIMET
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TREXIMET | Tablets | naproxen sodium; sumatriptan succinate | 500 mg/85 mg | 021926 | 1 | 2008-07-23 |
US Patents and Regulatory Information for TREXIMET
TREXIMET is protected by one US patents.
Patents protecting TREXIMET
Multilayer dosage forms containing NSAIDs and triptans
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>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 | See Plans and Pricing | See Plans and Pricing |
Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | See Plans and Pricing | See Plans and Pricing |
Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | See Plans and Pricing | See Plans and Pricing |
Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | See Plans and Pricing | See Plans and Pricing |
Currax | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-001 | Apr 15, 2008 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TREXIMET
When does loss-of-exclusivity occur for TREXIMET?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 03303631
Estimated Expiration: See Plans and Pricing
Austria
Patent: 6134
Estimated Expiration: See Plans and Pricing
Canada
Patent: 09023
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 12640
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 75566
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 75566
Estimated Expiration: See Plans and Pricing
Israel
Patent: 9041
Estimated Expiration: See Plans and Pricing
Japan
Patent: 16009
Estimated Expiration: See Plans and Pricing
Patent: 06515856
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 05006954
Estimated Expiration: See Plans and Pricing
Norway
Patent: 6458
Estimated Expiration: See Plans and Pricing
Patent: 053193
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 75566
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 75566
Estimated Expiration: See Plans and Pricing
Spain
Patent: 80827
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TREXIMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 8801788 | See Plans and Pricing | |
Egypt | 17283 | AN INDOLE DERIVATIVE | See Plans and Pricing |
Spain | 8801204 | See Plans and Pricing | |
Australia | 573878 | See Plans and Pricing | |
Spain | 557480 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TREXIMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1411900 | 2011/016 | Ireland | See Plans and Pricing | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
1411900 | 2011C/016 | Belgium | See Plans and Pricing | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1411900 | SPC/GB11/015 | United Kingdom | See Plans and Pricing | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
1411900 | 18/2011 | Austria | See Plans and Pricing | 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 |
1411900 | 122012000052 | Germany | See Plans and Pricing | PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |