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 | 021410-004 | 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 |
Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-002 | 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 |
>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 |
---|---|---|---|
Singapore | 83747 | SUBSTITUTED THIAZOLIDINEDIONE DERIVATIVES | ⤷ Try a Trial |
Hungary | 9601698 | ⤷ Try a Trial | |
Canada | 2179584 | COMPOSITION PHARMACEUTIQUE CONTENANT UN ACTIVATEUR DE LA SENSIBILITE A L'INSULINE EN COMBINAISON AVEC UN AUTRE ANTIDIABETIQUE (PHARMACEUTICAL COMPOSITION CONTAINING INSULIN SENSITIVITY ENHANCER IN COMBINATION WITH ANOTHER ANTIDIABETIC) | ⤷ Try a Trial |
Hungary | 229960 | Novel composition based on a thiazolidinedione and metformin and its use | ⤷ 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 | SPC026/2009 | Ireland | ⤷ Try a Trial | SPC026/2009: 20101001, EXPIRES: 20210619 |
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 |
1261586 | C300524 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION: |
1532149 | 132013902118390 | Italy | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |