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Generic Tyzeka Availability

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

TYZEKA (telbivudine - solution;oral)

  • Manufacturer: NOVARTIS
    Approval date: April 28, 2009
    Strength(s): 100MG/5ML

TYZEKA (telbivudine - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: October 25, 2006
    Strength(s): 600MG [RLD]

Has a generic version of Tyzeka been approved?

No. There is currently no therapeutically equivalent version of Tyzeka available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tyzeka. 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.

  • &bgr;-L-2′-deoxy-nucleosides for the treatment of hepatitis B
    Patent 6,395,716
    Issued: May 28, 2002
    Inventor(s): Gilles; Gosselin & Jean-Louis; Imbach & Martin L.; Bryant
    Assignee(s): Novirio Pharmaceuticals Limited Centre National da la Recherche Scientifique
    This invention is directed to a method for treating a host infected with hepatitis B comprising administering an effective amount of an anti-HBV biologically active 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof, wherein the 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside has the formula: wherein R is selected from the group consisting of H, straight chained, branched or cyclic alkyl, CO-alkyl, CO-aryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl, amino acid residue, mono, di, or triphosphate, or a phosphate derivative; and BASE is a purine or pyrimidine base which may be optionally substituted. The 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof may be administered either alone or in combination with another 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or in combination with another anti-hepatitis B agent.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
    • August 10, 2019
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
  • &bgr;-L-2'-deoxy-nucleosides for the treatment of hepatitis B
    Patent 6,444,652
    Issued: September 3, 2002
    Inventor(s): Gilles; Gosselin & Jean-Louis; Imbach & Martin L.; Bryant
    Assignee(s): Novirio Pharmaceuticals Limited Centre National da la Recherche Scientifique
    This invention is directed to a method for treating a host infected with hepatitis B comprising administering an effective amount of an anti-HBV biologically active 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof, wherein the 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside has the formula: wherein R is selected from the group consisting of H, straight chained, branched or cyclic alkyl, CO-alkyl, CO-aryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl, amino acid residue, mono, di, or triphosphate, or a phosphate derivative; and BASE is a purine or pyrimidine base which may be optionally substituted. The 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof may be administered either alone or in combination with another 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or in combination with another anti-hepatitis B agent.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
    • August 10, 2019
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
  • &bgr;-L-2′-deoxy-nucleosides for the treatment of hepatitis B
    Patent 6,566,344
    Issued: May 20, 2003
    Inventor(s): Gilles; Gosselin & Jean-Louis; Imbach & Martin L.; Bryant
    Assignee(s): Idenix Pharmaceuticals, Inc.
    This invention is directed to a method for treating a host infected with hepatitis B comprising administering an effective amount of an anti-HBV biologically active 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof, wherein the 2′-deoxy-&bgr;-L-erythro-pentoftiranonucleoside has the formula: wherein R is selected from the group consisting of H, straight chained, branched or cyclic alkyl, CO-alkyl, CO-aryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl, amino acid residue, mono, di, or triphosphate, or a phosphate derivative; and BASE is a purine or pyrimidine base which may be optionally substituted. The 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof may be administered either alone or in combination with another 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or in combination with another anti-hepatitis B agent.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
    • August 10, 2019
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
  • &bgr;-L-2′-deoxy pyrimidine nucleosides for the treatment of hepatitis B
    Patent 6,569,837
    Issued: May 27, 2003
    Inventor(s): Gilles; Gosselin & Jean-Louis; Imbach & Martin L.; Bryant
    Assignee(s): Idenix Pharmaceuticals Inc.
    This invention is directed to a method for treating a host infected with hepatitis B comprising administering an effective amount of an anti-HBV biologically active 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof, wherein the 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside has the formula: wherein R is selected from the group consisting of H, straight chained, branched or cyclic alkyl, CO-alkyl, CO-aryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl, amino acid residue, mono, di, or triphosphate, or a phosphate derivative; and BASE is a purine or pyrimidine base which may be optionally substituted. The 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof may be administered either alone or in combination with another 2′-deoxy-&bgr;-L-erythro-pentofuranonucleoside or in combination with another anti-hepatitis B agent.
    Patent expiration dates:
    • October 25, 2020
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
    • October 25, 2020
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
  • Crystalline and amorphous forms of beta-L-2′-deoxythymidine
    Patent 7,589,079
    Issued: September 15, 2009
    Inventor(s): Jonaitis; David & Storer; Richard
    Assignee(s): Novartis AG
    Physical forms of beta-L-2′-deoxythymidine are disclosed that can be characterized by physical appearance, purity levels, Infra-Red and Raman spectroscopy, X-ray powder diffraction patterns, thermal properties, and methods of manufacture. These forms of beta-L-2′-deoxythymidine can be used in the manufacture of other forms of beta-L-2′-deoxythymidine, or in pharmaceutical compositions. Particularly preferred uses are in the treatment of hepatitis B.
    Patent expiration dates:
    • September 11, 2023
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • β-L-2′-deoxy-nucleosides for the treatment of hepatitis B
    Patent 7,795,238
    Issued: September 14, 2010
    Inventor(s): Gosselin; Gilles & Imbach; Jean-Louis & Bryant; Martin L.
    Assignee(s): Idenix Pharmaceuticals, Inc. Centre National de la Recherche Scientifique L'Université Montpellier II
    This invention is directed to a method for treating a host infected with hepatitis B comprising administering an effective amount of an anti-HBV biologically active 2′-deoxy-β-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof, wherein the 2′-deoxy-β-L-erythro-pentofuranonucleoside has the formula: wherein R is selected from the group consisting of H, straight chained, branched or cyclic alkyl, CO-alkyl, CO-aryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl, amino acid residue, mono, di, or triphosphate, or a phosphate derivative; and BASE is a purine or pyrimidine base which may be optionally substituted. The 2′-deoxy-β-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof may be administered either alone or in combination with another 2′-deoxy-β-L-erythro-pentofuranonucleoside or in combination with another anti-hepatitis B agent.
    Patent expiration dates:
    • August 10, 2019
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
  • Crystalline and amorphous forms of beta-L-2′-deoxythymidine
    Patent 7,858,594
    Issued: December 28, 2010
    Inventor(s): Jonaitis; David & Storer; Richard
    Assignee(s): Novartis Pharma AG
    Physical forms of beta-L-2′-deoxythymidine are disclosed that can be characterized by physical appearance, purity levels, Infra-Red and Raman spectroscopy, X-ray powder diffraction patterns, thermal properties, and methods of manufacture. These forms of beta-L-2′-deoxythymidine can be used in the manufacture of other forms of beta-L-2′-deoxythymidine, or in pharmaceutical compositions. Particularly preferred uses are in the treatment of hepatitis B.
    Patent expiration dates:
    • September 11, 2023
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product

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:
    • January 28, 2016 - LONG TERM SAFETY AND EFFICACY DATA FROM STUDY CLDT600A2303 FOR SUBJECTS PREVIOUSLY ENROLLED IN THE ORIGINAL TWO YEAR GLOBE (NV-02B-007/CLDT600A2302) AND NV02B-015 STUDIES WHO CONTINUED TELBIVUDINE TREATMENT FOR UP TO 208 WEEKS

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.
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