Generic Reyataz Availability
REYATAZ (atazanavir sulfate - capsule;oral)
Manufacturer: BRISTOL MYERS SQUIBB
Approval date: June 20, 2003
Strength(s): EQ 100MG BASE [RLD], [RLD] [AB], [RLD] [AB]
Manufacturer: BRISTOL MYERS SQUIBB
Approval date: October 16, 2006
Strength(s): [RLD] [AB]
REYATAZ (atazanavir sulfate - powder;oral)
Has a generic version of Reyataz been approved?
A generic version of Reyataz 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 Reyataz and have been approved by the FDA:
Note: No generic formulation of the following product is available.
- atazanavir sulfate - powder;oral
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Reyataz. 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: Generic Drug FAQs.
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.
Antivirally active heterocyclic azahexane derivatives
Issued: December 15, 1998
Inventor(s): Fassler; Alexander & Bold; Guido & Capraro; Hans-Georg & Lang; Marc & Khanna; Satish Chandra
Assignee(s): Novartis Finance Corporation
There are described compounds of formula I*, ##STR1## wherein R.sub.1 is lower alkoxycarbonyl, R.sub.2 is secondary or tertiary lower alkyl or lower alkylthio-lower alkyl, R.sub.3 is phenyl that is unsubstituted or substituted by one or more lower alkoxy radicals, or C.sub.4 -C.sub.8 cycloalkyl, R.sub.4 is phenyl or cyclohexyl each substituted in the 4-position by unsaturated heterocyclyl that is bonded by way of a ring carbon atom, has from 5 to 8 ring atoms, contains from 1 to 4 hetero atoms selected from nitrogen, oxygen, sulfur, sulfinyl (--SO--) and sulfonyl (--SO.sub.2 --) and is unsubstituted or substituted by lower alkyl or by phenyl-lower alkyl, R.sub.5, independently of R.sub.2, has one of the meanings mentioned for R.sub.2, and R.sub.6, independently of R.sub.1, is lower alkoxycarbonyl, or salts thereof, provided that at least one salt-forming group is present. The compounds are inhibitors of retroviral aspartate protease and can be used, for example, in the treatment of AIDS. They exhibit outstanding pharmacodynamic properties.Patent expiration dates:
- June 20, 2017✓✓✓
- December 20, 2017✓
- June 20, 2017
Bisulfate salt of HIV protease inhibitor
Issued: July 11, 2000
Inventor(s): Singh; Janak & Pudipeddi; Madhusudhan & Lindrud; Mark D.
Assignee(s): Bristol-Myers Squibb Company
The present invention provides the crystalline bisulfate salt of the formula ##STR1## which is found to have unexpectedly high solubility/dissolution rate and oral bioavailability relative to the free base form of this azapeptide HIV protease inhibitor compound.Patent expiration dates:
- December 21, 2018✓✓
- June 21, 2019✓
- December 21, 2018
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- June 2, 2017 - NEW PRODUCT
- December 2, 2017 - PEDIATRIC EXCLUSIVITY
- September 24, 2018 - NEW PATIENT POPULATION
- March 24, 2019 - PEDIATRIC EXCLUSIVITY
More about Reyataz (atazanavir)
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- Generic Availability
- Drug class: protease inhibitors
- Reyataz (Atazanavir Capsules)
- Reyataz (Atazanavir Powder for Oral Suspension)
- Reyataz (Advanced Reading)
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.|