AVANDARYL Drug Patent Profile
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Which patents cover Avandaryl, and what generic alternatives are available?
Avandaryl is a drug marketed by Sb Pharmco and is included in one NDA.
The generic ingredient in AVANDARYL is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.
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Summary for AVANDARYL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 1 |
Patent Applications: | 1,690 |
DailyMed Link: | AVANDARYL at DailyMed |
Recent Clinical Trials for AVANDARYL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GlaxoSmithKline | Phase 3 |
Paragraph IV (Patent) Challenges for AVANDARYL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AVANDARYL | Tablets | glimepiride; rosiglitazone maleate | 8 mg/2 mg 8 mg/4 mg | 021700 | 1 | 2008-05-30 |
AVANDARYL | Tablets | glimepiride; rosiglitazone maleate | 1 mg/4 mg 2 mg/4 mg 4 mg/4 mg | 021700 | 1 | 2006-12-22 |
US Patents and Regulatory Information for AVANDARYL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-001 | Nov 23, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-003 | Nov 23, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-004 | Mar 30, 2007 | 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 AVANDARYL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-003 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-004 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-003 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AVANDARYL
See the table below for patents covering AVANDARYL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 307812 | ⤷ Sign Up | |
Gulf Cooperation Council | 0000250 | 5-Ä4-Ä2-(N-methyl-n-(2-pyridyl) amino) ethoxyÜ benzylÜthiazolidine-2,4-dione maleci acid salt | ⤷ Sign Up |
South Korea | 0169463 | ⤷ Sign Up | |
China | 1063942 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AVANDARYL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0306228 | SPC/GB01/002 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711 |
0658161 | CA 2001 00001 | Denmark | ⤷ Sign Up | |
0658161 | SPC/GB01/003 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711 |
0658161 | C300035 | Netherlands | ⤷ Sign Up | PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT. |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |