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Generic Sustiva Availability

Sustiva is a brand name of efavirenz, approved by the FDA in the following formulation(s):

SUSTIVA (efavirenz - capsule;oral)

SUSTIVA (efavirenz - tablet;oral)

Has a generic version of Sustiva been approved?

A generic version of Sustiva 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 Sustiva and have been approved by the FDA:

efavirenz tablet;oral

  • Manufacturer: MYLAN LABS LTD
    Approval date: February 17, 2016
    Strength(s): 600MG [AB]

Note: No generic formulation of the following product is available.

  • efavirenz - capsule;oral

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

  • Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
    Patent 6,238,695
    Issued: May 29, 2001
    Inventor(s): Makooi-Morehead; William T. & Buehler; John D. & Landmann; Brian R.
    Assignee(s): DuPont Pharmaceuticals Company
    The present invention provides improved oral dosage form formulations of efavirenz that are useful in the inhibition of human immunodeficiency virus (HIV), the prevention or treatment of infection by HIV, and in the treatment of the resulting acquired immune deficiency syndrome (AIDS). In particular, the present invention relates to compressed tablets or capsules comprising efavirenz that contain one or more disintegrants that enhance the dissolution rate of the efavirenz in the gastrointestinal tract thereby improving the rate and extent of absorption of efavirenz in the body. The present invention also relates to the process of making such tablets or capsules.
    Patent expiration dates:
    • April 6, 2019
      ✓ 
      Drug product
    • October 6, 2019
      ✓ 
      Pediatric exclusivity
  • Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
    Patent 6,555,133
    Issued: April 29, 2003
    Inventor(s): William T.; Makooi-Morehead & John D.; Buehler & Brian R.; Landmann
    Assignee(s): Bristol-Myers Squibb Company
    The present invention provides improved oral dosage form formulations of efavirenz that are useful in the inhibition of human immunodeficiency virus (HIV), the prevention or treatment of infection by HIV, and in the treatment of the resulting acquired immune deficiency syndrome (AIDS). In particular, the present invention relates to compressed tablets or capsules comprising efavirenz that contain one or more disintegrants that enhance the dissolution rate of the efavirenz in the gastrointestinal tract thereby improving the rate and extent of absorption of efavirenz in the body. The present invention also relates to the process of making such tablets or capsules.
    Patent expiration dates:
    • April 6, 2019
      ✓ 
      Patent use: TREATMENT OF HIV
    • October 6, 2019
      ✓ 
      Pediatric exclusivity
  • Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
    Patent 6,639,071
    Issued: October 28, 2003
    Inventor(s): Louis S.; Crocker & Joseph L.; Kukura, II & Andrew S.; Thompson & Christine; Stelmach & Steven D.; Young
    Assignee(s): Merck & Co., Inc.
    The instant invention describes a method for crystallizing (−)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one from a solvent and anti-solvent system and producing the crystalline product. The desired final crystal form, Form I, can be produced when using methanol or ethanol. Form II is isolated from 2-propanol and can be converted to the desired crystal form at low drying temperatures, such as between about a temperature of 40° C. and 50° C.
    Patent expiration dates:
    • February 14, 2018
      ✓ 
      Drug substance
    • August 14, 2018
      ✓ 
      Pediatric exclusivity
  • Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
    Patent 6,939,964
    Issued: September 6, 2005
    Inventor(s): Crocker; Louis S. & Kukura, II; Joseph L. & Thompson; Andrew S. & Stelmach; Christine & Young; Steven D.
    Assignee(s): Merck & Co., Inc.
    The instant invention describes a method for crystallizing (−)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one from a solvent and anti-solvent solvent system and producing the crystalline product. The desired final crystal form, Form I, can be produced when using methanol or ethanol. Form II is isolated from 2-propanol and can be converted to the desired crystal form at low drying temperatures, such as between about a temperature of 40° C. and 50° C.
    Patent expiration dates:
    • January 20, 2018
      ✓ 
      Drug substance
    • July 20, 2018
      ✓ 
      Pediatric exclusivity

Related Exclusivities

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:
    • May 2, 2016 - NEW PATIENT POPULATION
    • November 2, 2016 - PEDIATRIC EXCLUSIVITY

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.
ABProducts 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.
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