THIOTEPA - Generic Drug Details
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What are the generic sources for thiotepa and what is the scope of freedom to operate?
Thiotepa
is the generic ingredient in four branded drugs marketed by Immunex, Beloteca, Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Penn Life, Teva Parenteral, West-ward Pharms Int, Adienne Sa, Gland Pharma Ltd, Hikma, Meitheal, MSN, and Shorla, and is included in sixteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Thiotepa has two patent family members in one country.
There are eleven drug master file entries for thiotepa. Nine suppliers are listed for this compound.
Summary for THIOTEPA
| International Patents: | 2 |
| US Patents: | 1 |
| Tradenames: | 4 |
| Applicants: | 14 |
| NDAs: | 16 |
| Drug Master File Entries: | 11 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 243 |
| Patent Applications: | 7,491 |
| 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
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| 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 | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 217559-001 | Aug 20, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 214222-001 | Mar 8, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Penn Life | THIOTEPA | thiotepa | INJECTABLE;INJECTION | 208242-001 | Jan 10, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | THIOTEPA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 216037-001 | Dec 26, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Immunex | THIOPLEX | thiotepa | INJECTABLE;INJECTION | 020058-001 | Dec 22, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Shorla | TEPYLUTE | thiotepa | SOLUTION;INTRAVENOUS | 216984-001 | Jun 25, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
International Patents for THIOTEPA
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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.
ISSN: 2162-2639
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