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Didanosine - Generic Drug Details

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What are the generic sources for didanosine and what is the scope of didanosine freedom to operate?

Didanosine is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Barr, Mylan Pharms Inc, Bristol Myers Squibb, Bristol-myers Squibb, and Aurobindo, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for didanosine. Three suppliers are listed for this compound.

Summary for didanosine

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	9
Drug Master File Entries:	8
Suppliers / Packagers:	3
Bulk Api Vendors:	98
Clinical Trials:	144
Formulation / Manufacturing:	see details
DailyMed Link:	didanosine at DailyMed

Pharmacology for didanosine

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for didanosine

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for didanosine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-002	Oct 9, 1991		DISCN	Yes	No
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-004	Oct 9, 1991		DISCN	Yes	No
Mylan Pharms Inc	DIDANOSINE	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	090788-003	Apr 8, 2010		DISCN	No	No
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-006	Oct 28, 1999		DISCN	Yes	No
Aurobindo	DIDANOSINE	didanosine	TABLET, FOR SUSPENSION;ORAL	077275-001	Aug 14, 2012		DISCN	No	No

Expired US Patents for didanosine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-004	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-005	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-006	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-003	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-005	Oct 9, 1991