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NDA

DIDANOSINE | N020155 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

4 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

8 letters from Drugs@FDA

Date	Submission	Document
Dec 28, 2006	SUPPL -39	View Letter (PDF)
Sep 18, 2006	SUPPL -38	View Letter (PDF)
Jun 30, 2004	SUPPL -31	View Letter (PDF)
Jan 22, 2004	SUPPL -34	View Letter (PDF)
Mar 10, 2003	SUPPL -32	View Letter (PDF)
Sep 25, 2002	SUPPL -30	View Letter (PDF)
Apr 1, 2002	SUPPL -28	View Letter (PDF)
Oct 29, 1999	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#003 — 100MG/PACKET

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Oct 9, 1991

No patent or exclusivity listings for this strength.

#004 — 167MG/PACKET

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Oct 9, 1991

#005 — 250MG/PACKET

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Oct 9, 1991

#006 — 375MG/PACKET

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Oct 9, 1991