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HIVID

NDA

ZALCITABINE | N020199 | HOFFMANN LA ROCHE INC

2 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov — 3 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy NCT05979311	Phase 3	Active	ViiV Healthcare	307	2024-02-21 → 2027-02-23
Reducing Vertical Transmission of Hepatitis B in Africa NCT04704024	Phase 3	Active	University of Alabama at Birmingham	450	2021-09-03 → 2026-12-31
Sleep Outcomes and Multidimensional Assessment With Antiretroviral Therapy in People Living With HIV on Dolutegravir- vs Doravirine-Based Regimens NCT07673965	Phase 4	Not Yet Recruiting	University of Witwatersrand, South Africa	40	2026-08-20 → 2027-11-30
STARLITE for Unresectable High-Grade Gliomas NCT06428045	Phase 1	Recruiting	University of Miami	24	2025-04-15 → 2030-04-30
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up NCT07678268	Phase 4	Recruiting	Instituto Mexicano del Seguro Social	78	2025-07-10 → 2026-12-10

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — 0.375MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 19, 1992

No patent or exclusivity listings for this strength.

#002 — 0.75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 19, 1992