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Thiotepa - Generic Drug Details
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What are the generic drug sources for thiotepa and what is the scope of freedom to operate?
Thiotepa
is the generic ingredient in three branded drugs marketed by Immunex, Dr Reddys, Fresenius Kabi Usa, Jiangsu Hengrui Med, Sti Pharma Llc, Teva Parenteral, West-ward Pharms Int, Adienne Sa, and MSN, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for thiotepa. Six suppliers are listed for this compound.
Summary for thiotepa
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 9 |
NDAs: | 10 |
Drug Master File Entries: | 11 |
Suppliers / Packagers: | 6 |
Bulk Api Vendors: | 88 |
Clinical Trials: | 197 |
Patent Applications: | 7,475 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for thiotepa |
What excipients (inactive ingredients) are in thiotepa? | thiotepa excipients list |
DailyMed Link: | thiotepa at DailyMed |
Recent Clinical Trials for thiotepa
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Baptist Health South Florida | Phase 2 |
University of Birmingham | Phase 3 |
Gustave Roussy, Cancer Campus, Grand Paris | Phase 3 |
Pharmacology for thiotepa
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for thiotepa
US Patents and Regulatory Information for thiotepa
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 | |||
Msn | THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 213049-001 | Mar 4, 2020 | AP | RX | No | No | 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 | |||
Msn | THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 213049-002 | Mar 4, 2020 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Teva Parenteral | THIOTEPA | thiotepa | INJECTABLE;INJECTION | 075730-002 | Apr 20, 2001 | DISCN | No | No | 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 |
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