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avandia Drug Profile
» See Plans and Pricing
When do Avandia patents expire, and when can generic versions of Avandia launch?
Avandia is a drug marketed by Sb Pharmco and is included in one NDA. There is one patent protecting this drug.
This drug has forty-five patent family members in thirty-six countries.
The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rosiglitazone maleate profile page.
US ANDA Litigation and Generic Entry Outlook for Avandia
Avandia was eligible for patent challenges on May 25, 2003.
There are six tentative approvals for the generic drug (rosiglitazone maleate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for avandia
| International Patents: | 45 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 37 |
| Patent Applications: | 1,882 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for avandia |
| DailyMed Link: | avandia at DailyMed |
Recent Clinical Trials for avandia
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dan Zandberg | Phase 2 |
| Khoo Teck Puat Hospital | Phase 4 |
| Singapore Clinical Research Institute | Phase 4 |
Pharmacology for avandia
| Drug Class | Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione |
| Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
Paragraph IV (Patent) Challenges for AVANDIA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AVANDIA | TABLET;ORAL | rosiglitazone maleate | 021071 |
US Patents and Regulatory Information for avandia
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-002 | May 25, 1999 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-004 | May 25, 1999 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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 avandia
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | Start Trial | Start Trial |
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-004 | May 25, 1999 | Start Trial | Start Trial |
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-002 | May 25, 1999 | Start Trial | Start Trial |
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for avandia
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Yugoslavia | 75401 | Start Trial |
| South Africa | 9306509 | Start Trial |
| China | 1101911 | Start Trial |
| Finland | 106263 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for avandia
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0306228 | 38/2000 | Austria | Start Trial | PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929 |
| 0658161 | SPC/GB01/003 | United Kingdom | Start Trial | 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 | 01C0002 | France | Start Trial | PRODUCT NAME: MALEATE DE ROSIGLITAZONE OU L UN DE SES ISOMERES OU UNE DE SES FORMES TAUTOMERES ET/OU UN DE SES SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/00/137/001 DU 20000711; REGISTRATION NO/DATE AT EEC: IKS Nø 55 176 DU 19990929 |
| 0306228 | C300034 | Netherlands | Start Trial | PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
