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NORVIR

NDA

RITONAVIR | N020659 | 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Roxane Laboratories, Inc. v. Abbott Laboratories, et al. 2:2012cv00312	OHSD	2012-04-10	Terminated 2014-09-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)NCT07601074	Phase 2	Not Yet Recruiting	Daré Bioscience, Inc.	118	2026-06 → 2027-12
A Study to Learn About Effects of Living With COVID-19 and the Use of the Medicines Nirmatrelvir-Ritonavir in Treating COVID-19.NCT06085924	—	Completed	Pfizer	2,315,187	2023-11-07 → 2025-02-28
A Study to Learn How Paxlovid [Nirmatrelvir-ritonavir/PF-07321332] Works in COVID-19 Patients Who Are Elderly or Have Medical Conditions.NCT07261085	—	Completed	Pfizer	99,000	2025-10-27 → 2026-02-26

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

Medicare Part D Spending

CMS annual spending data for Norvir (2023)

Total Spending

$753K

Total Claims

1,933

Beneficiaries

393

Avg Cost/Unit

$8.72

Spending Trend

$5.8M(2019)→$2.5M(2020)→$1.6M(2021)→$1.1M(2022)→$753K(2023)

YoY Change:+3.8%

5yr CAGR:+2.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain15 active DMFs6 inactive

14 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

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

MYLAN LABORATORIES LTDInactiveRITONAVIR USP (FORM I)

DMF 198392006

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

32 letters from Drugs@FDA

Date	Submission	Document
Dec 16, 2022	SUPPL -73	View Letter (PDF)
Oct 22, 2020	SUPPL -72	View Letter (PDF)
Dec 23, 2019	SUPPL -71	View Letter (PDF)
Aug 22, 2019	SUPPL -70	View Letter (PDF)
Dec 7, 2018	SUPPL -69	View Letter (PDF)
Oct 3, 2017	SUPPL -68	View Letter (PDF)
Jun 30, 2017	SUPPL -66	View Letter (PDF)
Jun 8, 2017	SUPPL -67	View Letter (PDF)
Dec 23, 2016	SUPPL -64	View Letter (PDF)
Nov 23, 2016	SUPPL -63	View Letter (PDF)
Sep 19, 2016	SUPPL -65	View Letter (PDF)
Nov 17, 2015	SUPPL -62	View Letter (PDF)
Apr 3, 2015	SUPPL -61	View Letter (PDF)
Mar 17, 2015	SUPPL -60	View Letter (PDF)
Nov 8, 2013	SUPPL -58	View Letter (PDF)
Nov 23, 2012	SUPPL -57	View Letter (PDF)
Feb 27, 2012	SUPPL -56	View Letter (PDF)
Dec 8, 2011	SUPPL -55	View Letter (PDF)
May 3, 2010	SUPPL -50	View Letter (PDF)
Feb 17, 2010	SUPPL -45	View Letter (PDF)
Jan 20, 2010	SUPPL -47	View Letter (PDF)
Oct 2, 2008	SUPPL -43	View Letter (PDF)
Sep 3, 2008	SUPPL -42	View Letter (PDF)
May 20, 2008	SUPPL -39	View Letter (PDF)
Aug 2, 2007	SUPPL -40	View Letter (PDF)
May 16, 2007	SUPPL -36	View Letter (PDF)
Nov 18, 2005	SUPPL -33	View Letter (PDF)
Oct 11, 2005	SUPPL -34	View Letter (PDF)
Mar 30, 2005	SUPPL -32	View Letter (PDF)
Sep 25, 2003	SUPPL -30	View Letter (PDF)
Mar 14, 2002	SUPPL -27	View Letter (PDF)
Mar 6, 2001	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 80MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Mar 1, 1996

No patent or exclusivity listings for this strength.