FORTAMET Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Fortamet, and when can generic versions of Fortamet launch?
Fortamet is a drug marketed by Andrx Labs Llc and is included in one NDA.
The generic ingredient in FORTAMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fortamet
A generic version of FORTAMET was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.
Summary for FORTAMET
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 41 |
Patent Applications: | 680 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FORTAMET |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FORTAMET |
What excipients (inactive ingredients) are in FORTAMET? | FORTAMET excipients list |
DailyMed Link: | FORTAMET at DailyMed |
Recent Clinical Trials for FORTAMET
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
University of Colorado, Denver | Phase 1 |
St. Jude Children's Research Hospital | Phase 2 |
Pharmacology for FORTAMET
Drug Class | Biguanide |
Anatomical Therapeutic Chemical (ATC) Classes for FORTAMET
Paragraph IV (Patent) Challenges for FORTAMET
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FORTAMET | Extended-release Tablets | metformin hydrochloride | 500 mg and 1000 mg | 021574 | 1 | 2008-10-14 |
US Patents and Regulatory Information for FORTAMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | AB2 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 FORTAMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FORTAMET
See the table below for patents covering FORTAMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2087889 | Comprimé oral à libération contrôlée doté d'un coeur unitaire (Controlled release oral tablet having a unitary core) | ⤷ Sign Up |
Japan | 4557424 | ⤷ Sign Up | |
Australia | 2005239716 | ⤷ Sign Up | |
Japan | 2002506810 | ⤷ Sign Up | |
European Patent Office | 1335708 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORTAMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1730131 | C01730131/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
1412357 | C 2008 016 | Romania | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
2498758 | LUC00152 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
1532149 | 92128 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE |
1532149 | CA 2013 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |