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Last Updated: March 28, 2024

DACOGEN Drug Patent Profile


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Which patents cover Dacogen, and what generic alternatives are available?

Dacogen is a drug marketed by Otsuka and is included in one NDA.

The generic ingredient in DACOGEN is decitabine. There are eighteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the decitabine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dacogen

A generic version of DACOGEN was approved as decitabine by DR REDDYS on July 11th, 2013.

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Drug patent expirations by year for DACOGEN
Drug Prices for DACOGEN

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Recent Clinical Trials for DACOGEN

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

SponsorPhase
Franziska WachterPhase 2
Harvard Clinical and Translational Science Center (Harvard Catalyst)Phase 2
Jacqueline Garcia, MDPhase 1

See all DACOGEN clinical trials

Pharmacology for DACOGEN

US Patents and Regulatory Information for DACOGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka DACOGEN decitabine INJECTABLE;INTRAVENOUS 021790-001 May 2, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 DACOGEN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V.   Dacogen decitabine EMEA/H/C/002221
Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.
Authorised no no yes 2012-09-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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