Generic Atripla Availability

Atripla is a brand name of efavirenz/emtricitabine/tenofovir, approved by the FDA in the following formulation(s):

ATRIPLA (efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet;oral)

  • Manufacturer: GILEAD
    Approval date: July 12, 2006
    Strength(s): 600MG;200MG;300MG [RLD]

Has a generic version of Atripla been approved?

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

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

  • Benzoxazinones as inhibitors of HIV reverse transcriptase
    Patent 5,519,021
    Issued: May 21, 1996
    Inventor(s): Young; Steven D. & Britcher; Susan F. & Payne; Linda S. & Tran; Lekhanh O. & Lumma, Jr.; William C.
    Assignee(s): Merck & Co., Inc.
    Certain benzoxazinones are useful in the inhibition of HIV reverse transcriptase (including its resistant varieties), the prevention or treatment of infection by HIV and the treatment of AIDS, either as compounds, pharmaceutically acceptable salts, pharmaceutical composition ingredients, whether or not in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of treating AIDS and methods of preventing or treating infection by HIV are also described.
    Patent expiration dates:
    • November 21, 2013
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      Pediatric exclusivity
  • Benzoxazinones as inhibitors of HIV reverse transcriptase
    Patent 5,663,169
    Issued: September 2, 1997
    Inventor(s): Young; Steven D. & Payne; Linda S. & Britcher; Susan F. & Tran; Lekhanh O. & Lumma, Jr.; William C.
    Assignee(s): Merck & Co., Inc.
    Certain benzoxazinones are useful in the inhibition of HIV reverse transcriptase (including its resistant varieties), the prevention or treatment of infection by HIV and the treatment of AIDS, either as compounds, pharmaceutically acceptable saks, pharmaceutical composition ingredients, whether or not in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of treating AIDS and methods of preventing or treating infection by HIV are also described.
    Patent expiration dates:
    • September 2, 2014
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      Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • September 2, 2014
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
    • March 2, 2015
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      Pediatric exclusivity
  • Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds
    Patent 5,814,639
    Issued: September 29, 1998
    Inventor(s): Liotta; Dennis C. & Schinazi; Raymond F. & Choi; Woo-Baeg
    Assignee(s): Emory University
    The present invention relates to a method of preparing the antiviral compounds 2'-deoxy-5-fluoro-3'thiacytidine (FTC) and various prodrug analogues of FTC from inexpensive precursors with the option of introducing functionality as needed; methods of using these compounds, particularly in the prevention and treatment of AIDS; and the compounds themselves. This synthetic route allows the stereoselective preparation of the biologically active isomer of these compounds and related compounds.
    Patent expiration dates:
    • September 29, 2015
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      Drug substance
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      Drug product
    • March 29, 2016
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      Pediatric exclusivity
  • Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
    Patent 5,914,331
    Issued: June 22, 1999
    Inventor(s): Liotta; Dennis C. & Schinazi; Raymond F. & Choi; Woo-Baeg
    Assignee(s): Emory University
    A method and composition for the treatment of HIV and HBV infections in humans is disclosed that includes administering an effective amount of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, a pharmaceutically acceptable derivative thereof, including a 5' or N.sup.4 alkylated or acylated derivative, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier. A process for the resolution of a racemic mixture of nucleoside enantiomers is also disclosed that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers.
    Patent expiration dates:
    • July 2, 2017
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      Drug substance
    • January 2, 2018
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      Pediatric exclusivity
  • Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
    Patent 5,922,695
    Issued: July 13, 1999
    Inventor(s): Arimilli; Murty N. & Cundy; Kenneth C. & Dougherty; Joseph P. & Kim; Choung U. & Oliyai; Reza & Stella; Valentino J.
    Assignee(s): Gilead Sciences, Inc.
    Novel compounds are provided that comprise esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates having the structure --OC(R.sup.2).sub.2 OC(O)X(R).sub.a, wherein R.sup.2 independently is H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro or OR.sup.3 in which R.sup.3 is C.sub.1 -C12 alkyl; X is N or O; R is independently H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro, --O--, --N.dbd., --NR.sup.4 --, --N(R.sup.4).sub.2 -- or OR.sup.3, R.sup.4 independently is --H or C.sub.1 -C.sub.8 alkyl, provided that at least one R is not H; and a is 1 or 2, with the proviso that when a is 2 and X is N, (a) two R groups can be taken together to form a carbocycle or oxygen-containing heterocycle, or (b) one R additionally can be OR.sup.3. The compounds are useful as intermediates for the preparation of antiviral compounds or oligonucleotides, or are useful for administration directly to patients for antiviral therapy or prophylaxis. Embodiments are particularly useful when administered orally.
    Patent expiration dates:
    • July 25, 2017
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      Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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      Drug substance
    • July 25, 2017
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
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      Drug substance
    • January 25, 2018
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      Pediatric exclusivity
  • Nucleotide analog composition and synthesis method
    Patent 5,935,946
    Issued: August 10, 1999
    Inventor(s): Munger, Jr.; John D. & Rohloff; John C. & Schultze; Lisa M.
    Assignee(s): Gilead Sciences, Inc.
    The invention provides a composition comprising bis(POC)PMPA and fumaric acid (1:1). The composition is useful as an intermediate for the preparation of antiviral compounds, or is useful for administration to patients for antiviral therapy or prophylaxis. The composition is particularly useful when administered orally. The invention also provides methods to make PMPA and intermediates in PMPA synthesis. Embodiments include lithium t-butoxide, 9-(2-hydroxypropyl) adenine and diethyl p-toluenesulfonylmethoxyphosphonate in an organic solvent such as DMF. The reaction results in diethyl PMPA preparations containing an improved by-product profile compared to diethyl PMPA made by prior methods.
    Patent expiration dates:
    • July 25, 2017
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      Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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      Drug substance
      ✓ 
      Drug product
    • July 25, 2017
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
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      Drug substance
      ✓ 
      Drug product
    • January 25, 2018
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      Pediatric exclusivity
  • Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
    Patent 5,977,089
    Issued: November 2, 1999
    Inventor(s): Arimilli; Murty N. & Cundy; Kenneth C. & Dougherty; Joseph P. & Kim; Choung U. & Oliyai; Reza & Stella; Valentino J.
    Assignee(s): Gilead Sciences, Inc.
    Compounds are provided that comprise esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates having the structure --OC(R.sup.2).sub.2 OC(O)X(R).sub.a, wherein R.sup.2 independently is H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro or OR.sup.3 in which R.sup.3 is C.sub.1 -C.sub.12 alkyl; X is N or O; R is independently H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro, --O--, --N.dbd., --NR.sup.4 --, --N(R.sup.4).sub.2 -- or OR.sup.3, R.sup.4 independently is --H or C.sub.1 -C.sub.8 alkyl, provided that at least one R is not H; and a is 1 or 2, with the proviso that when a is 2 and X is N, (a) two R groups can be taken together to form a carbocycle or oxygen-containing heterocycle, or (b) one R additionally can be OR.sup.3. The compounds are useful as intermediates for the preparation of antiviral compounds or oligonucleotides, or are useful for administration directly to patients for antiviral therapy or prophylaxis. Embodiments are particularly useful when administered orally.
    Patent expiration dates:
    • July 25, 2017
      ✓ 
      Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 25, 2017
      ✓ 
      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 25, 2018
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      Pediatric exclusivity
  • Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
    Patent 6,043,230
    Issued: March 28, 2000
    Inventor(s): Arimilli; Murty N. & Cundy; Kenneth C. & Dougherty; Joseph P. & Kim; Choung U. & Oliyai; Reza & Stella; Valentino J.
    Assignee(s): Gilead Sciences, Inc.
    Novel compounds are provided that comprise esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates having the structure -OC(R.sup.2).sub.2 OC(O) X(R).sub.a, wherein R.sup.2 independently is H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro or OR.sup.3 in which R.sup.3 is C.sub.1 -C12 alkyl; X is N or O; R is independently H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, axido, nitro, --O--, --N.dbd., --NR.sup.4 --, --N(R.sup.4).sub.2 -- or OR.sup.3, R.sup.4 independently is --H or C.sub.1 -C.sub.8 alkyl, provided that at least one R is not H; and a is 1 or 2, with the proviso that when a is 2 and X is N, (a) two R groups can be taken together to form a carbocycle or oxygen-containing heterocycle, or (b) one R additionally can be OR.sup.3. The compounds are useful as intermediates for the preparation of antiviral compounds or oligonucleotides, or are useful for administration directly to patients for antiviral therapy or prophylaxis. Embodiments are particularly useful when administered orally.
    Patent expiration dates:
    • July 25, 2017
      ✓ 
      Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • July 25, 2017
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
    • January 25, 2018
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      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
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      Drug substance
    • August 14, 2018
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      Pediatric exclusivity
  • Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
    Patent 6,642,245
    Issued: November 4, 2003
    Inventor(s): Dennis C.; Liotta & Raymond F.; Schinazi & Woo-Baeg; Choi
    Assignee(s): Emory University
    A method and composition for the treatment of HIV and HBV infections in humans is disclosed that includes administering an effective amount of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, a pharmaceutically acceptable derivative thereof, including a 5′ or N4 alkylated or acylated derivative, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier. A process for the resolution of a racemic mixture of nucleoside enantiomers is also disclosed that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers.
    Patent expiration dates:
    • November 4, 2020
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      Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • November 4, 2020
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
    • May 4, 2021
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      Pediatric exclusivity
  • Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
    Patent 6,703,396
    Issued: March 9, 2004
    Inventor(s): Dennis C.; Liotta & Raymond F.; Schinazi & Woo-Baeg; Choi
    Assignee(s): Emory University
    A process for the resolution of a racemic mixture of nucleoside enantiomers that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers. The nucleoside enantiomer (−)-2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane is an effective antiviral agent against HIV, HBV, and other viruses replicating in a similar manner.
    Patent expiration dates:
    • March 9, 2021
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      Drug substance
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      Drug product
    • September 9, 2021
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      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
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      Drug substance
    • July 20, 2018
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      Pediatric exclusivity
  • Compositions and methods for combination antiviral therapy
    Patent 8,592,397
    Issued: November 26, 2013
    Assignee(s): Gilead Sciences, Inc.
    The present invention relates to therapeutic combinations of [2-(6-amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid diisopropoxycarbonyloxymethyl ester (tenofovir disoproxil fumarate, Viread®) and (2R, 5S, cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one(emtricitabine, Emtriva™, (-)-cis FTC) and their physiologically functional derivatives. The combinations may be useful in the treatment of HIV infections, including infections with HIV mutants bearing resistance to nucleoside and/or non-nucleoside inhibitors. The present invention is also concerned with pharmaceutical compositions and formulations of said combinations of tenofovir disoproxil fumarate and emtricitabine, and their physiologically functional derivatives, as well as therapeutic methods of use of those compositions and formulations.
    Patent expiration dates:
    • January 13, 2024
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      Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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      Drug product
    • January 13, 2024
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
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      Drug product
  • Unitary pharmaceutical dosage form
    Patent 8,598,185
    Issued: December 3, 2013
    Assignee(s): Bristol-Myers Squibb & Gilead Sciences, Inc.
    In accordance with this invention a novel pharmaceutical product containing efavirenz, emtricitabine and tenofovir DF are provided as a multicomponent unitary oral dosage form, component 1 comprising tenofovir DF (and, optionally, emtricitabine) and component 2 comprising efavirenz, wherein components 1 and 2 are in a stabilizing configuration. In preferred embodiments component 1 is made by dry granulation.
    Patent expiration dates:
    • May 1, 2028
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      Drug product
  • Compositions and methods for combination antiviral therapy
    Patent 8,716,264
    Issued: May 6, 2014
    Assignee(s): Gilead Sciences, Inc.
    The present invention relates to therapeutic combinations of [2-(6-amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid diisopropoxycarbonyloxymethyl ester (tenofovir disoproxil fumarate, Viread®) and (2R,5S,cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one (emtricitabine, Emtriva™, (−)-cis FTC) and their physiologically functional derivatives. The combinations may be useful in the treatment of HIV infections, including infections with HIV mutants bearing resistance to nucleoside and/or non-nucleoside inhibitors. The present invention is also concerned with pharmaceutical compositions and formulations of said combinations of tenofovir disoproxil fumarate and emtricitabine, and their physiologically functional derivatives, as well as therapeutic methods of use of those compositions and formulations.
    Patent expiration dates:
    • January 13, 2024
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      Patent use: TREATMENT OF HIV INFECTION
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      Drug product

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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