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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 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. Two 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:	2
Bulk Api Vendors:	101
Clinical Trials:	144
Patent Applications:	5,144
Formulation / Manufacturing:	see details
DailyMed Link:	didanosine at DailyMed

Recent Clinical Trials for didanosine

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

Sponsor	Phase
TTY Biopharm	Phase 1
Chang Gung Memorial Hospital	Phase 1
Asan Medical Center	Phase 4

See all didanosine clinical trials

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

Paragraph IV (Patent) Challenges for DIDANOSINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
VIDEX	FOR SOLUTION;ORAL	didanosine	020155	2011-06-06
VIDEX EC	CAPSULE, DELAYED REL PELLETS;ORAL	didanosine	021183	2004-06-01

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
Aurobindo	DIDANOSINE	didanosine	TABLET, FOR SUSPENSION;ORAL	077275-002	Aug 14, 2012		DISCN	No	No
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-003	Oct 9, 1991		DISCN	No	No
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-003	Oct 9, 1991		DISCN	Yes	No
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-002	Oct 9, 1991		DISCN	Yes	No
Aurobindo Pharma	DIDANOSINE	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	090094-001	Sep 24, 2008	AB	RX	No	No

Expired US Patents for didanosine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-002	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-004	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-006	Oct 9, 1991
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-001	Oct 31, 2000
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-005	Oct 9, 1991