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TEPADINA Drug Profile
» See Plans and Pricing
When do Tepadina patents expire, and when can generic versions of Tepadina launch?
Tepadina is a drug marketed by Adienne Sa and is included in one NDA.
The generic ingredient in TEPADINA is thiotepa. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
US ANDA Litigation and Generic Entry Outlook for Tepadina
A generic version of TEPADINA was approved as thiotepa by WEST-WARD PHARMS INT on April 2nd, 2001.
Summary for TEPADINA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 10 |
| Patent Applications: | 4,612 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TEPADINA at DailyMed |
Recent Clinical Trials for TEPADINA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Birmingham | Phase 3 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
| Fred Hutchinson Cancer Research Center | Phase 2 |
Pharmacology for TEPADINA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
US Patents and Regulatory Information for TEPADINA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adienne Sa | TEPADINA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264-001 | Jan 26, 2017 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Adienne Sa | TEPADINA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264-002 | Jan 26, 2017 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Adienne Sa | TEPADINA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264-001 | Jan 26, 2017 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Adienne Sa | TEPADINA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264-002 | Jan 26, 2017 | AP | 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 |
