Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
AstraZeneca
Mallinckrodt
McKinsey
Dow

Last Updated: August 11, 2022

TEPADINA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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.

  Try it Free

Drug patent expirations by year for TEPADINA
Drug Prices for TEPADINA

See drug prices for TEPADINA

Recent Clinical Trials for TEPADINA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nohla Therapeutics, Inc.Phase 2
Incyte CorporationPhase 1
Children's Oncology GroupPhase 2

See all TEPADINA clinical trials

Pharmacology for TEPADINA
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Colorcon
McKinsey
Medtronic
Baxter

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.