Generic Hepsera Availability
HEPSERA (adefovir dipivoxil - tablet;oral)
Has a generic version of Hepsera been approved?
A generic version of Hepsera 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 Hepsera and have been approved by the FDA:
Manufacturer: SIGMAPHARM LABS LLC
Approval date: August 29, 2013
Strength(s): 10MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Hepsera. 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.
Prodrugs of phosphonates
Issued: September 2, 1997
Inventor(s): Starrett, Jr.; John E. & Mansuri; Muzammil M. & Martin; John C. & Tortolani; David R. & Bronson; Joanne J.
Assignee(s): Institute of Organic Chemistry and Biochemistry of the Academy of Rega Stichting v.z.w.
There are disclosed novel oral prodrugs of phosphonate nucleotide analogs which are hydrolyzable under physiological conditions to yield compounds which are useful as antiviral agents, especially as agents effective against RNA and DNA viruses. They may also find use as antitumor agents.Patent expiration dates:
- September 2, 2014✓✓
- September 2, 2014
Nucleotide analog compositions
Issued: September 17, 2002
Inventor(s): Murty N.; Arimilli & Daphne E.; Kelly & Thomas T. K.; Lee & Lawrence V.; Manes & John D.; Munger, Jr. & Ernest J.; Prisbe & Lisa M.; Schultze
Assignee(s): Gilead Sciences, Inc.
The invention provides crystalline forms of adefovir dipivoxil and methods to prepare the crystals. The compositions and methods of the present invention have desirable properties for large scale synthesis of crystalline adefovir dipivoxil or for its formulation into therapeutic dosages. Invention compositions include an anhydrous crystal form of adefovir dipivoxil.Patent expiration dates:
- July 23, 2018✓✓✓
- July 23, 2018
- Hepsera Consumer Information (Wolters Kluwer)
- Hepsera Consumer Information (Cerner Multum)
- Hepsera AHFS DI Monographs (ASHP)
- Adefovir Consumer Information (Wolters Kluwer)
- Adefovir Consumer Information (Cerner Multum)
- Adefovir Advanced Consumer Information (Micromedex®)
- Adefovir Dipivoxil 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.|
|AB||Products 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.|