avandamet Drug Patent Profile
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Which patents cover Avandamet, and when can generic versions of Avandamet launch?
Avandamet is a drug marketed by Sb Pharmco and is included in one NDA.
The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.
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Summary for avandamet
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 14 |
Patent Applications: | 1,690 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for avandamet |
What excipients (inactive ingredients) are in avandamet? | avandamet excipients list |
DailyMed Link: | avandamet at DailyMed |
![avandamet drug patent expirations Drug patent expirations by year for avandamet](/p/graph/s/t/avandamet-patent-expirations.png)
Recent Clinical Trials for avandamet
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GlaxoSmithKline | Phase 1 |
M.D. Anderson Cancer Center | Phase 1 |
Susan G. Komen Breast Cancer Foundation | Phase 1 |
Paragraph IV (Patent) Challenges for AVANDAMET
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AVANDAMET | Tablets | metformin hydrochloride; rosiglitazone maleate | 1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg | 021410 | 1 | 2004-10-22 |
US Patents and Regulatory Information for avandamet
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-004 | Aug 25, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-002 | Oct 10, 2002 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-005 | Aug 25, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-001 | Oct 10, 2002 | 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 avandamet
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-001 | Oct 10, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-002 | Oct 10, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-005 | Aug 25, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-003 | Oct 10, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for avandamet
See the table below for patents covering avandamet around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1764110 | ⤷ Sign Up | |
Brazil | 1100841 | ⤷ Sign Up | |
Canada | 2370262 | ⤷ Sign Up | |
African Regional IP Organization (ARIPO) | 9300562 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for avandamet
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0861666 | 07C0006 | France | ⤷ Sign Up | PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728 |
1412357 | 50/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408 |
1506211 | 42/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |