Generic Bystolic Availability
BYSTOLIC (nebivolol hydrochloride - tablet;oral)
Manufacturer: FOREST LABS
Approval date: December 17, 2007
Strength(s): EQ 2.5MG BASE [AB], EQ 5MG BASE [AB], EQ 10MG BASE [AB]
Manufacturer: FOREST LABS
Approval date: October 8, 2008
Strength(s): EQ 20MG BASE [RLD] [AB]
Has a generic version of Bystolic been approved?
A generic version of Bystolic 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 Bystolic and have been approved by the FDA:
Manufacturer: AMERIGEN PHARMS LTD
Approval date: April 16, 2015
Strength(s): EQ 2.5MG BASE [AB], EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bystolic. 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.
Compositions containing micronized nebivolol
Issued: June 2, 1998
Inventor(s): Jans; Eugeen Marie Jozef & Smans; Guido Franciscus & Gilis; Paul Marie Victor
Assignee(s): Janssen Pharmaceutica, N.V.
The present invention relates to pharmaceutical compositions containing as active ingredient micronized nebivolol of formula (I) and ways of preparing said compositions. ##STR1##Patent expiration dates:
- June 2, 2015✓
- June 2, 2015
Method of lowering the blood pressure
Issued: April 8, 2003
Inventor(s): Raymond Mathieu; Xhonneux & Guy Rosalia Eugène; Van Lommen
Assignee(s): Janssen Pharmaceutica N.V.
A method of potentiating the effects of blood pressure reducing agents in warm-blooded animals, said method comprising administering to said warm-blooded animals of an effective amount of a blood pressure reducing agent and a 2,2′-iminobisethanol derivative.Patent expiration dates:
- December 17, 2021✓✓
- December 17, 2021
- Bystolic Consumer Information (Drugs.com)
- Bystolic Consumer Information (Wolters Kluwer)
- Bystolic Consumer Information (Cerner Multum)
- Bystolic Advanced Consumer Information (Micromedex®)
- Bystolic AHFS DI Monographs (ASHP)
- Nebivolol Consumer Information (Wolters Kluwer)
- Nebivolol Consumer Information (Cerner Multum)
- Nebivolol Advanced Consumer Information (Micromedex®)
- Nebivolol Hydrochloride 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.|