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Ribavirin - Generic Drug Details

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What are the generic drug sources for ribavirin and what is the scope of freedom to operate?

Ribavirin is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Chartwell Rx, Aurobindo Pharma, Teva, Zydus Pharms Usa, Navinta Llc, Valeant Pharm Intl, Schering, Roche, Beximco Pharms Usa, Heritage Pharma, and Sandoz, and is included in sixteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ribavirin has thirty-three patent family members in twenty-six countries.

There are fifteen drug master file entries for ribavirin. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ribavirin

International Patents:	33
US Patents:	1
Tradenames:	5
Applicants:	12
NDAs:	16
Drug Master File Entries:	15
Suppliers / Packagers:	9
Bulk Api Vendors:	94
Clinical Trials:	986
Patent Applications:	6,575
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ribavirin
DailyMed Link:	ribavirin at DailyMed

See drug prices for ribavirin

Recent Clinical Trials for ribavirin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Witwatersrand, South Africa	Phase 2
SynaVir	Phase 2
Rutgers, The State University of New Jersey	Phase 2

See all ribavirin clinical trials

Generic filers with tentative approvals for RIBAVIRIN

Applicant	Application No.	Strength	Dosage Form
		40MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ribavirin

Drug Class

Nucleoside Analog Antiviral

Medical Subject Heading (MeSH) Categories for ribavirin

Antimetabolites

Antiviral Agents

Paragraph IV (Patent) Challenges for RIBAVIRIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
VIRAZOLE	FOR SOLUTION;INHALATION	ribavirin	018859	2014-05-22
REBETOL	CAPSULE;ORAL	ribavirin	020903

US Patents and Regulatory Information for ribavirin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003		DISCN	Yes	No					Y
Zydus Pharms Usa	RIBAVIRIN	ribavirin	TABLET;ORAL	077094-004	Apr 18, 2008		DISCN	No	No
Heritage Pharma	RIBAVIRIN	ribavirin	TABLET;ORAL	077053-001	Dec 5, 2005		DISCN	No	No
Navinta Llc	RIBAVIRIN	ribavirin	FOR SOLUTION;INHALATION	207366-001	Oct 6, 2016	AN	RX	No	No
Chartwell Rx	RIBASPHERE	ribavirin	CAPSULE;ORAL	076203-001	Apr 6, 2004		DISCN	No	No
Roche	COPEGUS	ribavirin	TABLET;ORAL	021511-002	Jun 21, 2005		DISCN	No	No

Expired US Patents for ribavirin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001

International Patents for ribavirin

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03037312
Cyprus	1110524
Norway	334361
South Korea	100929320
Poland	205342
China	1582155