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NDA

DIDANOSINE | N020156 | BRISTOL MYERS SQUIBB CO

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

130 trials from ClinicalTrials.gov, 117 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings NCT00091936	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	592	2009-08
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection NCT00000652	Phase 1	Completed	National Cancer Institute (NCI)	85	— → 1995-11
A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease NCT00000656	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	116	— → 1993-11
A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment NCT00000671	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	750	—
An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex NCT00000672	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	660	—
A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone NCT00000870	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	200	— → 2007-03
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections NCT00001035	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	10	— → 1996-09
A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex NCT00000710	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	42	— → 1990-05
A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection NCT00006154	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	165	—
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)NCT00192660	Phase 4	Completed	Kirby Institute	80	2003-02 → 2007-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

APITORIA PHARMA PRIVATE LTDDIDANOSINE USP

DMF 176572004

APITORIA PHARMA PRIVATE LTDDIDANOSINE USP, NON-STERILE DRUG SUBSTANCE

DMF 208702007

MATRIX PHARMACORP PRIVATE LTDDIDANOSINE USP

DMF 212152007

HETERO LABS LTDInactiveDIDANOSINE

DMF 187332005

CIPLA LTDInactiveDIDANOSINE USP

DMF 197842008

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTDInactiveDIDANOSINE EUR.PH NON-STERILE DRUG SUBSTANCE

DMF 209472007

AURISCO PHARMACEUTICAL LTDInactiveDIDANOSINE

DMF 236352010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2018	SUPPL -54	View Letter (PDF)
Jan 30, 2018	SUPPL -53	View Letter (PDF)
Aug 12, 2014	SUPPL -51	View Letter (PDF)
Nov 22, 2011	SUPPL -48	View Letter (PDF)
May 12, 2011	SUPPL -47	View Letter (PDF)
Feb 1, 2010	SUPPL -46	View Letter (PDF)
Jun 17, 2009	SUPPL -44	View Letter (PDF)
Dec 28, 2006	SUPPL -40	View Letter (PDF)
Sep 18, 2006	SUPPL -39	View Letter (PDF)
Jan 22, 2004	SUPPL -35	View Letter (PDF)
Mar 10, 2003	SUPPL -33	View Letter (PDF)
Sep 25, 2002	SUPPL -32	View Letter (PDF)
Sep 25, 2002	SUPPL -31	View Letter (PDF)
Apr 1, 2002	SUPPL -29	View Letter (PDF)
Oct 29, 1999	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLD

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Oct 9, 1991

No patent or exclusivity listings for this strength.