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: | 3,007 |
| Formulation / Manufacturing: | see details |
| 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 | ||||
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-005 | 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 | 021700-005 | Mar 30, 2007 | ⤷ 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 | 021700-002 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-001 | 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 |
|---|---|---|---|
| Slovakia | 27795 | SUBSTITUTED THIAZOLIDINEDIONE DERIVATIVES | ⤷ Sign Up |
| Brazil | 1100916 | ⤷ Sign Up | |
| Australia | 2173888 | ⤷ Sign Up | |
| Japan | H10194970 | ANTIHYPERLIPIDEMIC MEDICINE CONTAINING SUBSTITUTED THIAZOLIDINEDIONE DERIVATIVE | ⤷ Sign Up |
| Argentina | 023560 | UNA FORMA POLIMORFICA DE ACIDO MALEICO DE UN DERIVADO DE TIAZOLIDIN-2,4-DIONA, COMPOSICION FARMACEUTICA Y EL USO DE LOS MISMOS PARA LA PREPARACION DE UNMEDICAMENTO | ⤷ Sign Up |
| Spain | 2133410 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AVANDARYL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0658161 | SPC001/2001 | Ireland | ⤷ Sign Up | SPC001/2001: 20050808, EXPIRES: 20140928 |
| 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 | 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 | 39/2000 | Austria | ⤷ Sign Up | PRODUCT NAME: ROSIGLITAZONE MALEAT; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929 |
| 0658161 | CA 2001 00001 | Denmark | ⤷ Sign Up | |
| 0306228 | 38/2000 | Austria | ⤷ Sign Up | PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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