THIOTEPA Drug Patent Profile
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When do Thiotepa patents expire, and what generic alternatives are available?
Thiotepa is a drug marketed by Beloteca, Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Immunex, Penn Life, Teva Parenteral, West-ward Pharms Int, Gland Pharma Ltd, Hikma, Meitheal, and MSN. and is included in thirteen NDAs.
The generic ingredient in THIOTEPA is thiotepa. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Thiotepa
A generic version of THIOTEPA was approved as thiotepa by WEST-WARD PHARMS INT on April 2nd, 2001.
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Questions you can ask:
- What is the 5 year forecast for THIOTEPA?
- What are the global sales for THIOTEPA?
- What is Average Wholesale Price for THIOTEPA?
Summary for THIOTEPA
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 243 |
| Drug Prices: | Drug price information for THIOTEPA |
| DailyMed Link: | THIOTEPA at DailyMed |
Recent Clinical Trials for THIOTEPA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | Phase 1 |
| Fred Hutchinson Cancer Center | Phase 2 |
| National Cord Blood Network | Phase 2 |
Pharmacology for THIOTEPA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for THIOTEPA
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Beloteca | THIOTEPA | thiotepa | INJECTABLE;INJECTION | 211831-001 | Dec 8, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Parenteral | THIOTEPA | thiotepa | INJECTABLE;INJECTION | 075730-001 | Apr 20, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hengrui Pharma | THIOTEPA | thiotepa | INJECTABLE;INJECTION | 209150-001 | May 4, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 214222-002 | Jan 3, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Parenteral | THIOTEPA | thiotepa | INJECTABLE;INJECTION | 075730-002 | Apr 20, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msn | THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 213049-001 | Mar 4, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for THIOTEPA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| ADIENNE S.r.l. S.U. | Tepadina | thiotepa | EMEA/H/C/001046 In combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.". It is proposed that Tepadina must be prescribed by physicians experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation. |
Authorised | no | no | no | 2010-03-15 | |
| Esteve Pharmaceuticals GmbH | Thiotepa Riemser | thiotepa | EMEA/H/C/005434 Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients |
Authorised | yes | no | no | 2021-03-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
