FORTAMET Drug Patent Profile
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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-five 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.
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Questions you can ask:
- What is the 5 year forecast for FORTAMET?
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- What is Average Wholesale Price for FORTAMET?
Summary for FORTAMET
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 43 |
| Patent Applications: | 579 |
| 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 |
|---|---|
| Arthritis Foundation | Phase 2 |
| Brigham and Women's Hospital | Phase 2 |
| University of Colorado, Denver | Phase 1 |
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 | 021574-001 | 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 | 021574-002 | 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 | 2010159290 | CONTROLLED RELEASE TABLET | ⤷ Sign Up |
| Australia | 739226 | ⤷ Sign Up | |
| Japan | 5427677 | ⤷ Sign Up | |
| Hong Kong | 1037963 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORTAMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261586 | 132012902044560 | Italy | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124 |
| 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 |
| 1412357 | 132008901682802 | Italy | ⤷ Sign Up | 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 |
| 1506211 | 122014000071 | Germany | ⤷ Sign Up | 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 | CA 2008 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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