TEPADINA Drug Patent 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. Eight 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: | 101 |
| Clinical Trials: | 28 |
| Patent Applications: | 7,331 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TEPADINA |
| 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 |
|---|---|
| Nohla Therapeutics, Inc. | Phase 2 |
| Incyte Corporation | Phase 1 |
| Children's Oncology Group | Phase 2 |
Pharmacology for TEPADINA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for TEPADINA
US Patents and Regulatory Information for TEPADINA
TEPADINA is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting TEPADINA
INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Adienne Sa | TEPADINA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264-002 | Jan 26, 2017 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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 TEPADINA
| 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 |
