Fortamet Drug Patent Profile
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Which patents cover Fortamet, and what generic alternatives are available?
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 |
---|---|
University of Colorado, Denver | Phase 1 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
St. Baldrick's Foundation | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 Fortamet
International Patents for Fortamet
See the table below for patents covering Fortamet around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2324493 | COMPRIMES ORAUX A NOYAU MONOLITHIQUE A LIBERATION CONTROLEE (CONTROLLED RELEASE ORAL TABLET HAVING A UNITARY CORE) | ⤷ Try a Trial |
Canada | 2427195 | COMPOSITIONS DE METFORMINE A LIBERATION CONTROLEE (CONTROLLED RELEASE METFORMIN COMPOSITIONS) | ⤷ Try a Trial |
Japan | 2010159290 | CONTROLLED RELEASE TABLET | ⤷ Try a Trial |
Mexico | PA03003994 | COMPOSICIONES DE METFORMINA DE LIBERACION CONTROLADA. (CONTROLLED RELEASE METFORMIN COMPOSITIONS.) | ⤷ Try a Trial |
China | 1158999 | ⤷ Try a Trial | |
Japan | 2013237689 | CONTROLLED RELEASE TABLET | ⤷ Try a Trial |
European Patent Office | 1335708 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Fortamet
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | PA2008013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 |
2498758 | PA2020003,C2498758 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1412357 | PA2008013,C1412357 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 |
1506211 | 122014000071 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1412357 | 77 5006-2008 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408 |
1506211 | 179 5017-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116 |
1412357 | 132008901682802 | Italy | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |