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Generic BiDil Availability

BiDil is a brand name of hydralazine/isosorbide dinitrate, approved by the FDA in the following formulation(s):

BIDIL (hydralazine hydrochloride; isosorbide dinitrate - tablet;oral)

  • Manufacturer: ARBOR PHARMS LLC
    Approval date: June 23, 2005
    Strength(s): 37.5MG;20MG [RLD]

Has a generic version of BiDil been approved?

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

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

  • Methods of treating and preventing congestive heart failure with hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate
    Patent 6,465,463
    Issued: October 15, 2002
    Inventor(s): Jay N.; Cohn & Peter; Carson
    Assignee(s): NitroMed, Inc.
    The present invention provides methods or treating and preventing mortality associated with heart failure in an African American patient with hypertension and improving oxygen consumption, quality of life and exercise tolerance by administering a therapeutically effective amount of at least one hydralazine compound and at least one of isosorbide dinitrate and isosorbide mononitrate, and, optionally, one or more compounds, such as, for example, a digitalis, a diuretic compound, or a compound used to treat cardiovascular diseases. In the present invention, the hydralazine compound is preferably hydralazine or a pharmaceutically acceptable salt thereof. Preferred methods of the invention comprise administering hydralazine or a pharmaceutically acceptable salt thereof and isosorbide dinitrate.
    Patent expiration dates:
    • September 8, 2020
      ✓ 
      Patent use: METHOD OF TREATMENT OF HEART FAILURE
  • Methods using hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate
    Patent 6,784,177
    Issued: August 31, 2004
    Inventor(s): Jay N.; Cohn & Peter; Carson
    Assignee(s): Nitro Med, Inc.
    The present invention provides methods of treating and preventing mortality associated with heart failure in an African American patient with hypertension, and improving oxygen consumption, quality of life and exercise tolerance by administering a therapeutically effective amount of at least one hydralazine compound and at least one of isosorbide dinitrate and isosorbide mononitrate, and, optionally, one or more compounds, such as, for example, a digitalis, a diuretic compound, or a compound used to treat cardiovascular diseases. In the present invention, the hydralazine compound is preferably hydralazine or a pharmaceutically acceptable salt thereof. Preferred methods of the invention comprise administering hydralazine or a pharmaceutically acceptable salt thereof and isosorbide dinitrate.
    Patent expiration dates:
    • September 8, 2020
      ✓ 
      Patent use: METHOD OF TREATMENT OF HEART FAILURE

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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