DECITABINE - Generic Drug Details

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What are the generic drug 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, Hetero Labs Ltd Vi, 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-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for DECITABINE

US Patents:	0
Tradenames:	2
Applicants:	21
NDAs:	21
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	450
Patent Applications:	6,878
Drug Prices:	Drug price trends for DECITABINE
What excipients (inactive ingredients) are in DECITABINE?	DECITABINE excipients list
DailyMed Link:	DECITABINE at DailyMed

See drug prices for DECITABINE

Recent Clinical Trials for DECITABINE

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

Sponsor	Phase
Benjamin Tomlinson	Phase 1/Phase 2
Pamela Munster	Phase 1
University Hospital Tuebingen	Phase 2

See all DECITABINE clinical trials

Pharmacology for DECITABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DECITABINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for DECITABINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nivagen Pharms Inc	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	212117-001	Dec 7, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	210984-001	Sep 16, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	205539-001	Nov 23, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	207100-001	Mar 16, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otsuka	DACOGEN	decitabine	INJECTABLE;INTRAVENOUS	021790-001	May 2, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 DECITABINE

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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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