Top PLR Article Directory Saint Kitts and Nevis: Rebetol

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

REBETOL (ribavirin - capsule; oral)

Manufacturer: SCHERING PLOUGH RES

Approval date: June 3, 1998

Strength(s): 200MG ^[RLD]

Manufacturer: SCHERING PLOUGH RES

Approval date: July 25, 2001

Strength(s): 200MG ^[RLD]^[AB]

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.

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
  ✓
  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
  ✓
  Pediatric exclusivity
- March 21, 2018
  ✓
  Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
  ✓
  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 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
- November 1, 2016
  ✓
  Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
- May 1, 2017
  ✓
  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
  ✓
  Pediatric exclusivity
- 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 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 PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
- 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
  ✓
  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
  ✓
  Pediatric exclusivity
- May 1, 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
  ✓
  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 PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL COMBINATION THERAPY
- 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 RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
- March 21, 2018
  ✓
  Patent use: METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL COMBINATION THERAPY
  ✓
  Pediatric exclusivity
- March 21, 2018
  ✓
  Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
  ✓
  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 REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEG-INTRON POWDER FOR INJECTION
- November 1, 2016
  ✓
  Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
- May 1, 2017
  ✓
  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
  ✓
  Pediatric exclusivity
- 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
  ✓
  Patent use: METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
  ✓
  Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- July 29, 2010 - ORPHAN DRUG EXCLUSIVITY
- January 29, 2011 - PEDIATRIC EXCLUSIVITY

Top PLR Article Directory Saint Kitts and Nevis

Tuesday, August 4, 2009

Rebetol