Generic Epivir-HBV Availability
See also: Generic Epivir
EPIVIR-HBV (lamivudine - solution;oral)
EPIVIR-HBV (lamivudine - tablet;oral)
Has a generic version of Epivir-HBV been approved?
No. There is currently no therapeutically equivalent version of Epivir-HBV available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Epivir-HBV. 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.
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.
Crystalline oxathiolane derivatives
Issued: May 18, 1999
Inventor(s): Roberts; Tony Gordon & Evans; Paul
Assignee(s): Glaxo Group Limited
(-)cis-4-Amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(IH)-pyrimidine-2-on e in crystalline form, in particular as needle-shaped or bypyramidyl crystals, pharmaceutical formulations thereof, methods for their preparation and their use in medicine.Patent expiration dates:
- May 18, 2016
- November 18, 2016✓
- May 18, 2016
Pharmaceutical compositions containing lamivudine
Issued: December 21, 1999
Inventor(s): Casey; Warren Michael & Nguyen; Ngoc-Anh Thi
Assignee(s): Glaxo Wellcome Inc.
The present invention relates to pharmaceutical formulations containing (2R, cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2 -one (-)-2',3'-dideoxy,3'-thiacytidine, lamivudine, that are substantially free of ethanol and ethylenediamine-tetraacitic acid, and their use in medical therapy.Patent expiration dates:
- March 20, 2018
- September 20, 2018✓
- March 20, 2018
Use of 1,3-oxathiolane nucleoside analogues in the treatment of hepatitis B
Issued: July 4, 2006
Inventor(s): Nguyen-Ba; Nghe
Assignee(s): Shire BioChem Inc.
Use of a compound of formula (I) or a pharmaceutically acceptable derivative thereof in the manufacture of a medicament for the treatment of hepatitis B is disclosed.Patent expiration dates:
- July 2, 2013✓
- January 2, 2014✓
- July 2, 2013
- Epivir-HBV Consumer Information (Wolters Kluwer)
- Epivir-HBV solution Consumer Information (Wolters Kluwer)
- Epivir HBV Consumer Information (Cerner Multum)
- Epivir HBV Advanced Consumer Information (Micromedex)
- Lamivudine Consumer Information (Wolters Kluwer)
- Lamivudine solution Consumer Information (Wolters Kluwer)
- Lamivudine Consumer Information (Cerner Multum)
- 3tc Advanced Consumer Information (Micromedex)
- Epivir A/F Advanced Consumer Information (Micromedex)
- Heptovir Advanced Consumer Information (Micromedex)
- Lamivudine Advanced Consumer Information (Micromedex)
- Lamivudine AHFS DI Monographs (ASHP)
|Drug Patent||A 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 Exclusivity||Exclusivity 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.|
|RLD||A 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.|