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REBETOL

NDA

RIBAVIRIN | N020903 | MERCK SHARP AND DOHME CORP

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from BioPartners GmbH FDA-2002-P-0168 · 8 docket documents BioPartners GmbH filed this suitability petition under Section 505(j)(2)(C) requesting FDA approval to file an ANDA for ribavirin, USP in water-soluble film-coated tablets, a new dosage form differing from the reference listed drug REBETOL (ribavirin capsules). The petitioner argued that the tablet	Other	2009-11-25	Withdrawn	BioPartners GmbH

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

Clinical Trials

464 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 361 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Hemorrhagic Fever With Ribavirin NCT04283513	Phase 2	Active	U.S. Army Medical Research and Development Command	50	2022-10-31 → 2027-07
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
Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever NCT02483260	N/A	By Invitation	U.S. Army Medical Research and Development Command	30	2016-06-16 → 2028-12
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C NCT01779518	—	APPROVED_FOR_MARKETING	Gilead Sciences	—	—
A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1 NCT01479868	Phase 3	Completed	Janssen R&D Ireland	109	2011-10 → 2013-08
PEG-Interferon a-2b + Ribavirin for Treatment of Chronic HRN 005 Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon NCT00215891	Phase 3	Completed	Hepatitis Resource Network	300	—
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)NCT01447420	Phase 4	Completed	Hoffmann-La Roche	129	2011-02 → 2012-11
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults NCT02476617	Phase 3	Completed	AbbVie	25	2015-06 → 2016-12
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)NCT01371604	Phase 2	Completed	Merck Sharp & Dohme LLC	68	2011-07 → 2014-10
A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis NCT01516918	Phase 2	Completed	Vertex Pharmaceuticals Incorporated	103	2012-02 → 2013-12

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

API Supply Chain5 active DMFs9 inactive

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

SIEGFRIED EVIONNAZ SARIBAVIRIN

DMF 121561996

YUHAN CHEMICAL INCRIBAVIRIN USP, 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-BETA-D-RIBOFURANOSYL

DMF 156112001

CURIA ITALY SRLRIBAVIRIN USP-EP

DMF 157002001

APITORIA PHARMA PRIVATE LTDRIBAVIRIN USP

DMF 189732005

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDRIBAVIRIN

DMF 268452012

ORGAMOL SAInactiveRIBAVIRIN

DMF 56871985

HEINRICH MACK NACHFInactiveRIBAVIRIN

DMF 64961986

YAMASA CORPInactiveRIBAVIRIN

DMF 127661997

STAR LAKE BIOSCIENCE CO INCInactiveRIBAVIRIN, USP

DMF 155032001

XINXIANG PHARMACEUTICAL CO LTDInactiveRIBAVIRIN NON-STERILE BULK FORM

DMF 156552001

BIDACHEM SPAInactiveRIBAVIRIN

DMF 157562001

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveRIBAVIRIN (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 192132006

EUTICALS SPAInactiveRIBAVIRIN

DMF 230042009

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFEInactiveRIBAVIRIN USP EP

DMF 230232009

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

Approval Letters

36 letters from Drugs@FDA

Date	Submission	Document
Mar 17, 2022	SUPPL -57	View Letter (PDF)
Jan 29, 2020	SUPPL -56	View Letter (PDF)
May 3, 2019	SUPPL -55	View Letter (PDF)
May 22, 2015	SUPPL -53	View Letter (PDF)
Nov 18, 2013	SUPPL -52	View Letter (PDF)
Jun 4, 2013	SUPPL -51	View Letter (PDF)
Feb 8, 2013	SUPPL -50	View Letter (PDF)
May 10, 2011	SUPPL -48	View Letter (PDF)
Nov 3, 2010	SUPPL -46	View Letter (PDF)
Jan 20, 2010	SUPPL -43	View Letter (PDF)
Jan 20, 2010	SUPPL -44	View Letter (PDF)
Jan 20, 2010	SUPPL -42	View Letter (PDF)
Jan 20, 2010	SUPPL -45	View Letter (PDF)
Jan 9, 2008	SUPPL -40	View Letter (PDF)
Apr 20, 2007	SUPPL -39	View Letter (PDF)
Sep 18, 2006	SUPPL -38	View Letter (PDF)
Jun 24, 2004	SUPPL -34	View Letter (PDF)
Jun 14, 2004	SUPPL -30	View Letter (PDF)
Jun 10, 2004	SUPPL -33	View Letter (PDF)
Oct 16, 2003	SUPPL -32	View Letter (PDF)
Jul 31, 2003	SUPPL -25	View Letter (PDF)
Jun 22, 2003	SUPPL -28	View Letter (PDF)
Jun 8, 2003	SUPPL -29	View Letter (PDF)
Sep 3, 2002	SUPPL -23	View Letter (PDF)
Mar 6, 2002	SUPPL -20	View Letter (PDF)
Feb 21, 2002	SUPPL -15	View Letter (PDF)
Dec 28, 2001	SUPPL -13	View Letter (PDF)
Jul 26, 2001	SUPPL -12	View Letter (PDF)
Jul 26, 2001	SUPPL -11	View Letter (PDF)
Jul 26, 2001	SUPPL -8	View Letter (PDF)
Jul 26, 2001	SUPPL -16	View Letter (PDF)
Mar 13, 2001	SUPPL -6	View Letter (PDF)
Mar 13, 2001	SUPPL -7	View Letter (PDF)
Dec 9, 1998	SUPPL -1	View Letter (PDF)
Dec 9, 1998	SUPPL -2	View Letter (PDF)
Jun 3, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 3, 1998

No patent or exclusivity listings for this strength.

#002 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jul 25, 2001