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TEPADINA Drug Profile
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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. Seven suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 16 |
| Patent Applications: | 4,495 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in TEPADINA? | TEPADINA excipients list |
| DailyMed Link: | TEPADINA at DailyMed |
Recent Clinical Trials for TEPADINA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Oncology Group | Phase 2 |
| Dana-Farber Cancer Institute | Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
Pharmacology for TEPADINA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
ATC Classes for TEPADINA
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 | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Adienne Sa | TEPADINA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264-002 | Jan 26, 2017 | AP | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
