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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs8 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

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