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 | 021410-001 | 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 | 021410-003 | 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 |
>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 |
---|---|---|---|
Mexico | 9602399 | COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.) | ⤷ Try a Trial |
Argentina | 065389 | COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLUCEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES | ⤷ Try a Trial |
Canada | 2388846 | ⤷ Try a Trial | |
Slovakia | 6792002 | PHARMACEUTICAL COMPOSITION AND PROCESS FOR THE PREPARATION THEREOF | ⤷ Try a Trial |
Japan | H10194971 | ANTIHYPERTENSIVE MEDICINE CONTAINING SUBSTITUTED THIAZOLIDINEDIONE DERIVATIVE | ⤷ 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 |
---|---|---|---|---|
1506211 | CA 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
1174135 | CA 2009 00045 | Denmark | ⤷ Try a Trial | |
0861666 | SPC 038/2006 | Ireland | ⤷ Try a Trial | SPC 038/2006: 20070528, EXPIRES: 20210619 |
2498758 | 132020000000034 | Italy | ⤷ Try a Trial | PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113 |
1412357 | C300357 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |