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NORVIR

NDA

RITONAVIR | N209512 | ABBVIE INC

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

500 trials from ClinicalTrials.gov, 1 active, 498 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment NCT02460133	Phase 4	Active	Nova Scotia Health Authority	44	2015-07-10 → 2025-10
Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection NCT00097799	—	APPROVED_FOR_MARKETING	Boehringer Ingelheim	—	2004-12
A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules NCT00281606	Phase 4	Completed	University of California, San Diego	65	2006-02-14 → 2012-06-13
Trial of Treatments for COVID-19 in Hospitalized Adults NCT04315948	Phase 3	Completed	Institut National de la Santé Et de la Recherche Médicale, France	1,552	2020-03-22 → 2023-09-25
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients NCT00002178	Phase 3	Completed	Hoffmann-La Roche	375	—
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children NCT00919854	Phase 2	Completed	Tibotec Pharmaceuticals, Ireland	27	2009-09 → 2011-02
MARCH Renal Substudy NCT01637259	Phase 4	Completed	Kirby Institute	76	2012-06 → 2015-12
Single Dose Escalation Study of GSK2838232 in Healthy Subjects NCT01802918	Phase 1	Completed	GlaxoSmithKline	17	2013-02-18 → 2013-11-21
Pharmacokinetics of Tipranavir Soft Elastic Capsules (SEDDS) and Ritonavir and Their Effects on Cytochrome P-450 (3A4) in Healthy Volunteers NCT02251132	Phase 1	Completed	Boehringer Ingelheim	113	2000-10
Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male Subjects NCT02251158	Phase 1	Completed	Boehringer Ingelheim	30	2003-10

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$187.06

Highest Price

$250.70

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-3399-30NORVIR 100MG POWDER,ORAL PKT	$187.06	Big4	Abbvie US LLC	07/31/2030
00074-3399-30NORVIR 100MG POWDER,ORAL PKT	$250.70	FSS	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain16 active DMFs8 inactive

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

APITORIA PHARMA PRIVATE LTDRITONAVIR USP

DMF 190372005

MATRIX PHARMACORP PRIVATE LTDRITONAVIR USP (FORM-II)

DMF 198002006

DR REDDYS LABORATORIES LTDRITONAVIR USP

DMF 235912010

OLON SPARITONAVIR

DMF 239352010

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDRITONAVIR USP

DMF 243832010

HETERO DRUGS LTDRITONAVIR USP (FORM I), PROCESS II

DMF 246292011

HETERO DRUGS LTDRITONAVIR PREMIX AMORPHOUS

DMF 261782012

CIPLA LTDRITONAVIR USP

DMF 264432013

EMCURE PHARMACEUTICALS LTDRITONAVIR USP (PROCESS II)

DMF 264632012

RAKS PHARMA PVT LTDRITONAVIR, USP (FORM-I)

DMF 281282014

LAURUS LABS LTDRITONAVIR USP

DMF 333422019

HETERO LABS LTDRITONAVIR USP

DMF 334782019

ARENE LIFE SCIENCES PRIVATE LTDRITONAVIR USP

DMF 348462020

CHROMO LABORATORIES INDIA PRIVATE LTDRITONAVIR USP

DMF 353032020

RUYUAN HEC PHARM CO LTDRITONAVIR NON-STERILE BULK DRUG SUBSTANCE

DMF 366732022

LUPIN MANUFACTURING SOLUTIONS LTDRITONAVIR USP

DMF 370502022

FINORGA SASInactiveRITONAVIR

DMF 116661995

CATALENT PHARMA SOLUTIONS LLCInactiveRITONAVIR, 100MG AND 200MG SOFT-GELATIN CAPSULE

DMF 127471997

MYLAN LABORATORIES LTDInactiveRITONAVIR USP (FORM I)

DMF 198392006

HETERO DRUGS LTDInactiveRITONAVIR, USP (FORM I), PROCESS I

DMF 202702007

RANBAXY LABORATORIES LTDInactiveRITONAVIR

DMF 211452007

LUPIN LTDInactiveRITONAVIR USP

DMF 235422010

EMCURE PHARMACEUTICALS LTDInactiveRITONAVIR USP

DMF 240302010

LUPIN LTDInactiveRITONAVIR COPOVIDONE

DMF 247152011

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jul 27, 2026	SUPPL -10	View Letter (PDF)
Dec 16, 2022	SUPPL -8	View Letter (PDF)
Oct 22, 2020	SUPPL -7	View Letter (PDF)
Dec 23, 2019	SUPPL -6	View Letter (PDF)
Aug 22, 2019	SUPPL -5	View Letter (PDF)
Dec 7, 2018	SUPPL -4	View Letter (PDF)
Mar 8, 2018	ORIG -1	View Letter (PDF)
Oct 3, 2017	SUPPL -2	View Letter (PDF)
Jun 30, 2017	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/PACKET

RLD

0 patents0 exclusivities▴

POWDER;ORAL | Approved: Jun 7, 2017

No patent or exclusivity listings for this strength.