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NORVIR

NDA

RITONAVIR | N020945 | 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Matrix Laboratories, Inc. - Citizen Petition FDA-2007-P-0483 · 6 docket documents Matrix Laboratories Limited, India submitted a petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Ritonavir Tablets, 100 mg are suitable for submission as an Abbreviated New Drug Application, with the reference listed drug being NORVIR c	Other	2008-06-17	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

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
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs NCT03537404	Phase 1	Completed	R-Pharm	36	2017-04-24 → 2017-06-30
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children NCT00000913	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	50	— → 2001-04
A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients NCT00002223	N/A	Completed	Abbott	—	—
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV NCT00027339	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	53	— → 2005-06
Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth NCT00102960	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	377	2005-07 → 2013-01
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects NCT00296504	Phase 3	Completed	ViiV Healthcare	753	2001-11 → 2010-10
Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects NCT00358917	Phase 3	Completed	Abbott	599	2006-08 → 2008-11

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

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

30 letters from Drugs@FDA

Date	Submission	Document
Oct 22, 2020	SUPPL -48	View Letter (PDF)
Dec 23, 2019	SUPPL -47	View Letter (PDF)
Aug 22, 2019	SUPPL -46	View Letter (PDF)
Dec 7, 2018	SUPPL -45	View Letter (PDF)
Jun 30, 2017	SUPPL -44	View Letter (PDF)
Jan 17, 2017	SUPPL -42	View Letter (PDF)
Nov 23, 2016	SUPPL -41	View Letter (PDF)
Sep 20, 2016	SUPPL -43	View Letter (PDF)
Nov 13, 2015	SUPPL -40	View Letter (PDF)
Apr 1, 2015	SUPPL -39	View Letter (PDF)
Mar 18, 2015	SUPPL -38	View Letter (PDF)
Nov 8, 2013	SUPPL -36	View Letter (PDF)
Nov 21, 2012	SUPPL -35	View Letter (PDF)
Apr 2, 2012	SUPPL -33	View Letter (PDF)
Feb 23, 2012	SUPPL -34	View Letter (PDF)
Dec 8, 2011	SUPPL -32	View Letter (PDF)
Apr 29, 2010	SUPPL -28	View Letter (PDF)
Jan 20, 2010	SUPPL -26	View Letter (PDF)
Oct 2, 2008	SUPPL -23	View Letter (PDF)
Sep 3, 2008	SUPPL -22	View Letter (PDF)
May 20, 2008	SUPPL -19	View Letter (PDF)
Aug 2, 2007	SUPPL -20	View Letter (PDF)
May 16, 2007	SUPPL -18	View Letter (PDF)
Nov 18, 2005	SUPPL -16	View Letter (PDF)
Oct 11, 2005	SUPPL -17	View Letter (PDF)
Mar 30, 2005	SUPPL -14	View Letter (PDF)
Jun 10, 2004	ORIG -1	View Letter (PDF)
Sep 25, 2003	SUPPL -13	View Letter (PDF)
Mar 14, 2002	SUPPL -8	View Letter (PDF)
Mar 6, 2001	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 29, 1999

No patent or exclusivity listings for this strength.