Generic Nitrostat Availability
NITROSTAT (nitroglycerin - injectable;injection)
Manufacturer: PARKE DAVIS
Approved Prior to Jan 1, 1982
Manufacturer: PARKE DAVIS
Approval date: December 23, 1983
NITROSTAT (nitroglycerin - tablet;sublingual)
Manufacturer: PFIZER PHARMS
Approval date: May 1, 2000
Strength(s): 0.3MG [AB], 0.4MG [AB], 0.6MG [RLD] [AB]
Has a generic version of Nitrostat been approved?
A generic version of Nitrostat 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 Nitrostat and have been approved by the FDA:
Manufacturer: DR REDDYS LABS INC
Approval date: August 26, 2016
Strength(s): 0.3MG [AB], 0.4MG [AB], 0.6MG [AB]
Note: No generic formulation of the following product is available.
- nitroglycerin - injectable;injection
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nitrostat. 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.
Compressed nitroglycerin tablet and its method of manufacture
Issued: December 31, 2002
Inventor(s): Roberto L.; Capella
Assignee(s): Warner-Lambert Company
The present invention is directed to a stable nitroglycerin containing pharmaceutical composition, preferably a tablet which is prepared by direct compression technology. The formulation closely replicates the properties of nitroglycerin molded sublingual tablets (e.g. adequate disintegration and sublingual absorption), while reducing the problems experienced with compressed tablets (e.g. friability and weight variations). The stable tablets are characterized by a decreased migration of nitroglycerin, decreased potency loss, excellent content uniformity when stored. The preferred combination of components are: nitroglycerin/lactose dilution, hydrous lactose, glyceril monostearate, fumed silica, pregelantinized starch and calcium stearate. The preferred process employs direct compression technology to yield composition showing adequate disintegration, bioavailability and improved stability.Patent expiration dates:
- September 16, 2018
- September 16, 2018
More about Nitrostat (nitroglycerin)
Related treatment guides
|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.|