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ZIDOVUDINE

NDA

ZIDOVUDINE | N200732 | PHARMOBEDIENT CONSULTING LLC

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

362 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 333 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Early Infant HIV Treatment in Botswana NCT02369406	Phase 2/3	Active	Harvard School of Public Health (HSPH)	67	2015-05-04 → 2029-06-30
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity NCT00092222	Phase 2	Active	National Cancer Institute (NCI)	75	2004-10-28 → 2026-10-01
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)NCT01419561	Phase 2	Recruiting	National Cancer Institute (NCI)	140	2011-09-08 → 2028-12-31
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
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient NCT00000661	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	8	—
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	—
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 Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir NCT00001095	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	94	— → 1999-10

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

API Supply Chain10 active DMFs10 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDZIDOVUDINE USP

DMF 166772003

APITORIA PHARMA PRIVATE LTDZIDOVUDINE USP

DMF 176382004

MATRIX PHARMACORP PRIVATE LTDZIDOVUDINE USP (PROCESS-I)

DMF 177512004

HETERO LABS LTDZIDOVUDINE (PROCESS I)

DMF 182912005

APITORIA PHARMA PRIVATE LTDZIDOVUDINE USP

DMF 187142005

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDZIDOVUDINE USP

DMF 212772008

HEC PHARM CO LTDZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM

DMF 237622010

HETERO LABS LTDZIDOVUDINE (PROCESS II)

DMF 246082011

SOLARA ACTIVE PHARMA SCIENCES LTDZIDOVUDINE

DMF 250092011

SHANGHAI SHYNDEC PHARMACEUTICAL HAIMEN CO LTDZIDOVUDINE

DMF 272072013

HOUBA INCInactiveZIDOVUDINE

DMF 97121992

ST PHARM CO LTDInactiveZIDOVUDINE DRUG SUBSTANCE

DMF 131811998

MATRIX LABORATORIES LTDInactiveZIDOVUDINE, USP

DMF 179522004

RANBAXY LABORATORIES LTDInactiveZIDOVUDINE USP DRUG SUBSTANCE

DMF 207032007

SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISEInactiveZIDOVUDINE USP

DMF 213252008

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)InactiveZIDOVUDINE USP

DMF 215702008

MYLAN LABORATORIES LTDInactiveZIDOVUDINE USP (PROCESS II)

DMF 244502010

MYLAN LABORATORIES LTDInactiveZIDOVUDINE USP (PROCESS III)

DMF 245502010

MATRIX PHARMA GROUP XIAMEN LTDInactiveZIDOVUDINE USP

DMF 250822011

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTDInactiveZIDOVUDINE (NON-STERILE, BULK FORM)

DMF 266952012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 30, 2019	SUPPL -2	View Letter (PDF)
Feb 28, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 23, 2011

No patent or exclusivity listings for this strength.