AVANDAMET Drug Patent Profile
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When do Avandamet patents expire, and what generic alternatives are available?
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.
Summary for AVANDAMET
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 14 |
Patent Applications: | 2,652 |
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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for AVANDAMET
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
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 | 021410-003 | Oct 10, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-003 | Oct 10, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-001 | Oct 10, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-005 | Aug 25, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-004 | Aug 25, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
South Korea | 100744361 | ⤷ Try a Trial | |
Slovakia | 287351 | ⤷ Try a Trial | |
Denmark | 175176 | ⤷ Try a Trial | |
Japan | H10194970 | ANTIHYPERLIPIDEMIC MEDICINE CONTAINING SUBSTITUTED THIAZOLIDINEDIONE DERIVATIVE | ⤷ Try a Trial |
Israel | 146115 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AVANDAMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1174135 | SPC/GB10/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU |
1506211 | 122014000070 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1261586 | C01261586/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329 |
1506211 | 132014902277722 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116 |
1412357 | C 2008 016 | Romania | ⤷ Try a Trial | 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 |