Didanosine - Generic Drug Details

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.

Summary for didanosine

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	9
Drug Master File Entries:	8
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	155
Patent Applications:	6,957
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in didanosine?	didanosine excipients list
DailyMed Link:	didanosine at DailyMed

Recent Clinical Trials for didanosine

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

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

See all didanosine clinical trials

Medical Subject Heading (MeSH) Categories for didanosine

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for didanosine

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DIDANOSINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIDEX	Capsules	didanosine	75 mg	020155	1	2011-06-06
VIDEX EC	Delayed-release Capsules	didanosine	200 mg, 250 mg and 400 mg	021183	1	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
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-003	Oct 9, 1991		DISCN	Yes	No
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-005	Oct 9, 1991		DISCN	Yes	No
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-005	Oct 9, 1991		DISCN	No	No
Mylan Pharms Inc	DIDANOSINE	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	090788-001	Apr 8, 2010		DISCN	No	No
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-003	Oct 9, 1991		DISCN	No	No
Aurobindo Pharma	DIDANOSINE	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	090094-003	Sep 24, 2008		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	FOR SOLUTION;ORAL	020155-005	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-002	Oct 9, 1991
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-003	Oct 9, 1991
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-005	Oct 9, 1991