Generic Rebetol Availability

Rebetol is a brand name of ribavirin, approved by the FDA in the following formulation(s):

REBETOL (ribavirin - capsule;oral)

REBETOL (ribavirin - solution;oral)

  • Manufacturer: SCHERING
    Approval date: July 29, 2003
    Strength(s): 40MG/ML [RLD]

Has a generic version of Rebetol been approved?

A generic version of Rebetol has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Rebetol and have been approved by the FDA:

RIBASPHERE (ribavirin capsule;oral)

  • Manufacturer: THREE RIVERS PHARMS
    Approval date: April 6, 2004
    Strength(s): 200MG [AB]

RIBAVARIN (ribavirin capsule;oral)

  • Manufacturer: AUROBINDO PHARMA
    Approval date: September 17, 2009
    Strength(s): 200MG [AB]

ribavirin capsule;oral

  • Manufacturer: SANDOZ
    Approval date: April 6, 2004
    Strength(s): 200MG [AB]
  • Manufacturer: TEVA
    Approval date: October 4, 2004
    Strength(s): 200MG [AB]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: October 28, 2005
    Strength(s): 200MG [AB]

Note: No generic formulation of the following product is available.

  • ribavirin - solution;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rebetol. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection
    Patent 6,172,046
    Issued: January 9, 2001
    Inventor(s): Albrecht; Janice K.
    Assignee(s): Schering Corporation
    There is disclosed a method for treating a patient having chronic hepatitis C infection to eradicate detectable HCV-RNA involving a combination therapy using a therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of from 20 up to 80 weeks.
    Patent expiration dates:
    • September 21, 2017
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • September 21, 2017
      ✓ 
      Patent use: METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL LOAD GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN COMBINATION OF RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS
    • September 21, 2017
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • March 21, 2018
      ✓ 
      Pediatric exclusivity
  • Polyethylene glycol modified interferon therapy
    Patent 6,177,074
    Issued: January 23, 2001
    Inventor(s): Glue; Paul & Cutler; David L. & Affrime; Melton B.
    Assignee(s): Schering Corporation
    A method comprising administering a PEG.sub.12000 -IFN alpha conjugate to an individual afflicted with a viral infection susceptible of treatment with interferon alpha, preferably chronic hepatitis C, is disclosed.
    Patent expiration dates:
    • November 1, 2016
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • November 1, 2016
      ✓ 
      Patent use: METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN, IN COMBINATION, A CONJUGATE COMPRISING PEG 12000 & INTERFERON ALFA-2B IN AN AMT OF FROM 0.5MCG/KG TO 2MCG/KG, ONCE WEEKLY, AND RIBAVIRIN
    • May 1, 2017
      ✓ 
      Pediatric exclusivity
  • Continuous low-dose cytokine infusion therapy
    Patent 6,461,605
    Issued: October 8, 2002
    Inventor(s): David L.; Cutler & Melton B.; Affrime
    Assignee(s): Schering Corporation
    A method is provided for treating conditions that are susceptible of treatment with a cytokine wherein the undesirable side effects normally associated with cytokine administration are diminished or eliminated. The method comprises continuously administering a low dose of a cytokine to an individual afflicted with a condition susceptible of treatment with the cytokine. In a preferred embodiment of the invention, chronic hepatitis C is treated by administering a low dose amount of interferon.
    Patent expiration dates:
    • November 1, 2016
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • November 1, 2016
      ✓ 
      Patent use: METHOD OF TREATING HEPATITIS C VIRAL INFECTION BY CONTINUOUS PARENTERAL ADMIN INTERFERON ALPHA 2-10 MILLION IU WEEKLY, SUBCUTANEOUSLY, INJECTION OF POLYMER-INTERFERON ALPHA CONJUGATE-POLYMER IS PEG-INTERFERON IS ALPHA 2B
    • November 1, 2016
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • May 1, 2017
      ✓ 
      Pediatric exclusivity
  • Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
    Patent 6,472,373
    Issued: October 29, 2002
    Inventor(s): Janice K.; Albrecht
    Assignee(s): Schering Corporation
    Methods for treating an antiviral treatment naive patient having chronic hepatitis C infection to eradicate detectable HCV-RNA involving administering a therapeutically effective amount of a combination therapy of ribavirin and interferon-alpha for a time period of from 20 up to 50 weeks are disclosed.
    Patent expiration dates:
    • September 21, 2017
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • September 21, 2017
      ✓ 
      Patent use: METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL COMBINATION THERAPY
    • September 21, 2017
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • March 21, 2018
      ✓ 
      Pediatric exclusivity
  • Polyethylene glycol modified interferon therapy
    Patent 6,524,570
    Issued: February 25, 2003
    Inventor(s): Paul; Glue & David L.; Cutler & Melton B.; Affrime
    Assignee(s): Schering Corporation
    A method comprising administering a PEG12000-IFN alpha conjugate to an individual afflicted with a viral infection susceptible of treatment with interferon alpha, preferably chronic hepatitis C, is disclosed.
    Patent expiration dates:
    • November 1, 2016
      ✓ 
      Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
    • November 1, 2016
      ✓ 
      Patent use: METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEG-INTRON POWDER FOR INJECTION
    • May 1, 2017
      ✓ 
      Pediatric exclusivity
  • Ribavirin syrup formulations
    Patent 6,790,837
    Issued: September 14, 2004
    Inventor(s): Susan K.; Heimbecher & Joel A.; Sequeira
    Assignee(s): Schering Corporation
    A liquid formulation comprising ribavirin having a longer shelf life and improved taste is disclosed.
    Patent expiration dates:
    • April 5, 2023
      ✓ 
      Drug product
    • October 5, 2023
      ✓ 
      Pediatric exclusivity

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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