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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 |
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 |
Generic filers with tentative approvals for RIBAVIRIN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 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
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 | Start Trial | Start Trial | Y | Start Trial | |||
Zydus Pharms Usa | RIBAVIRIN | ribavirin | TABLET;ORAL | 077094-004 | Apr 18, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Heritage Pharma | RIBAVIRIN | ribavirin | TABLET;ORAL | 077053-001 | Dec 5, 2005 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Navinta Llc | RIBAVIRIN | ribavirin | FOR SOLUTION;INHALATION | 207366-001 | Oct 6, 2016 | AN | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Chartwell Rx | RIBASPHERE | ribavirin | CAPSULE;ORAL | 076203-001 | Apr 6, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Roche | COPEGUS | ribavirin | TABLET;ORAL | 021511-002 | Jun 21, 2005 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | Start Trial | Start Trial |
Merck Sharp Dohme | REBETOL | ribavirin | CAPSULE;ORAL | 020903-001 | Jun 3, 1998 | Start Trial | Start Trial |
Merck Sharp Dohme | REBETOL | ribavirin | CAPSULE;ORAL | 020903-002 | Jul 25, 2001 | Start Trial | Start Trial |
Merck Sharp Dohme | REBETOL | ribavirin | CAPSULE;ORAL | 020903-001 | Jun 3, 1998 | Start Trial | Start Trial |
Merck Sharp Dohme | REBETOL | ribavirin | CAPSULE;ORAL | 020903-002 | Jul 25, 2001 | Start Trial | Start Trial |
Merck Sharp Dohme | REBETOL | ribavirin | CAPSULE;ORAL | 020903-002 | Jul 25, 2001 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ribavirin
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 03037312 | Start Trial |
Cyprus | 1110524 | Start Trial |
Norway | 334361 | Start Trial |
South Korea | 100929320 | Start Trial |
Poland | 205342 | Start Trial |
China | 1582155 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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