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DIABETA Drug Profile
» See Plans and Pricing
Which patents cover Diabeta, and when can generic versions of Diabeta launch?
Diabeta is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in DIABETA is glyburide. There are twenty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the glyburide profile page.
US ANDA Litigation and Generic Entry Outlook for Diabeta
A generic version of DIABETA was approved as glyburide by TEVA on August 29th, 1995.
Summary for DIABETA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 114 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,608 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DIABETA at DailyMed |
Recent Clinical Trials for DIABETA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis | Phase 2 |
| Takeda | Phase 4 |
| Takeda | Phase 3 |
US Patents and Regulatory Information for DIABETA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-001 | May 1, 1984 | AB2 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-002 | May 1, 1984 | AB2 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-003 | May 1, 1984 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | 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 DIABETA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-003 | May 1, 1984 | Start Trial | Start Trial |
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-003 | May 1, 1984 | Start Trial | Start Trial |
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-002 | May 1, 1984 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DIABETA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Finland | 275574 | Start Trial |
| Switzerland | 521952 | Start Trial |
| Sweden | 334605 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
