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 |
---|---|---|---|
Japan | 2008208142 | SUBSTITUTED THIAZOLIDINEDIONE DERIVATIVE | ⤷ Try a Trial |
Serbia | 51343 | NOVA KOMPOZICIJA I NJENA UPOTREBA (NOVEL COMPOSITION AND USE) | ⤷ Try a Trial |
Japan | H10194971 | ANTIHYPERTENSIVE MEDICINE CONTAINING SUBSTITUTED THIAZOLIDINEDIONE DERIVATIVE | ⤷ Try a Trial |
European Patent Office | 2289556 | ⤷ Try a Trial | |
Russian Federation | 2128179 | SUBSTITUTED THIAZOLIDINEDIONE AND METHOD OF PREPARING THEREOF | ⤷ 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 |
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 |
0861666 | SPC 038/2006 | Ireland | ⤷ Try a Trial | SPC 038/2006: 20070528, EXPIRES: 20210619 |
1261586 | 12C0028 | France | ⤷ Try a Trial | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
1412357 | PA2008013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |