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Last Updated: March 28, 2024

Decitabine - Generic Drug Details


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What are the generic sources for decitabine and what is the scope of patent protection?

Decitabine is the generic ingredient in two branded drugs marketed by Otsuka, Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, MSN, Nivagen Pharms Inc, Novast Labs, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for decitabine. Twenty-five suppliers are listed for this compound.

Drug Prices for decitabine

See drug prices for decitabine

Recent Clinical Trials for decitabine

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

SponsorPhase
IBFMPhase 1/Phase 2
Princess Maxima Center for Pediatric OncologyPhase 1/Phase 2
Fight Kids CancerPhase 1/Phase 2

See all decitabine clinical trials

Pharmacology for decitabine

US Patents and Regulatory Information for decitabine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm DECITABINE decitabine POWDER;INTRAVENOUS 205582-001 Jan 28, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma DECITABINE decitabine INJECTABLE;INTRAVENOUS 214569-001 Sep 20, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chemi Spa DECITABINE decitabine INJECTABLE;INTRAVENOUS 206033-001 Sep 22, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare DECITABINE decitabine INJECTABLE;INTRAVENOUS 203475-001 Feb 27, 2017 AP RX No Yes ⤷  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 decitabine

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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