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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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