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Last Updated: July 4, 2020

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REBETOL Drug Profile


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Which patents cover Rebetol, and when can generic versions of Rebetol launch?

Rebetol is a drug marketed by Merck Sharp Dohme and Schering and is included in two NDAs. There is one patent protecting this drug.

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

The generic ingredient in REBETOL is ribavirin. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

US ANDA Litigation and Generic Entry Outlook for Rebetol

A generic version of REBETOL was approved as ribavirin by ZYDUS PHARMS USA on October 28th, 2005.

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Drug patent expirations by year for REBETOL
Drug Prices for REBETOL

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Recent Clinical Trials for REBETOL

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SponsorPhase
Weill Medical College of Cornell UniversityEarly Phase 1
Gilead SciencesN/A
R-PharmPhase 3

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Pharmacology for REBETOL
Paragraph IV (Patent) Challenges for REBETOL
Tradename Dosage Ingredient NDA Submissiondate
REBETOL CAPSULE;ORAL ribavirin 020903

US Patents and Regulatory Information for REBETOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 DISCN Yes No   Start Trial   Start Trial Y   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 REBETOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003   Start Trial   Start Trial
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Colorcon
Merck
Johnson and Johnson
Mallinckrodt

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