Generic Stribild Availability

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

STRIBILD (cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate - tablet;oral)

• Manufacturer: GILEAD SCIENCES INC
  Approval date: August 27, 2012
  Strength(s): 150MG;150MG;200MG;300MG ^[RLD]

Has a generic version of Stribild been approved?

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

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

• 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 INFECTION
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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 INFECTION
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    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
    
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    Patent use: TREATMENT OF HIV INFECTION
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    Drug substance
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    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
    
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    Patent use: TREATMENT OF HIV INFECTION
  • January 25, 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 INFECTION
  • 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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  • September 9, 2021
    
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    Pediatric exclusivity
• 4-oxoquinoline compound and use thereof as pharmaceutical agent
  Patent 7,176,220
  Issued: February 13, 2007
  Inventor(s): Satoh; Motohide & Kawakami; Hiroshi & Itoh; Yoshiharu & Shinkai; Hisashi & Motomura; Takahisa & Aramaki; Hisateru & Matsuzaki; Yuji & Watanabe; Wataru & Wamaki; Shuichi
  Assignee(s): Japan Tobacco Inc.
  An anti-HIV agent containing, as an active ingredient, a 4-oxoquinoline compound represented by the following formula [I] wherein each symbol is as defined in the specification, or a pharmaceutically acceptable salt thereof. The compound of the present invention has HIV integrase inhibitory action and is useful as an anti-HIV agent for the prophylaxis or therapy of AIDS. Moreover, by a combined use with other anti-HIV agents such as protease inhibitors, reverse transcriptase inhibitors and the like, the compound can become a more effective anti-HIV agent. Since the compound has high inhibitory activity specific for integrases, it can provide a safe pharmaceutical agent with a fewer side effects for human.
  
  Patent expiration dates:
  • August 27, 2026
    
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    Patent use: TREATMENT OF HIV INFECTION
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• Stable crystal of 4-oxoquinoline compound
  Patent 7,635,704
  Issued: December 22, 2009
  Inventor(s): Satoh; Motohide & Motomura; Takahisa & Matsuda; Takashi & Kondo; Kentaro & Ando; Koji & Matsuda; Koji & Miyake; Shuji & Uehara; Hideto
  Assignee(s): Japan Tobacco Inc.
  Provision of a stabilized crystal of 6-(3-chloro-2-fluorobenzyl)-1-[(S)-1-hydroxymethyl-2-methylpropyl]-7-methoxy-4-oxo-1, 4-dihydroquinoline-3-carboxylic acid (compound A). A crystal of compound A, which shows a particular X-ray powder diffraction pattern of a characteristic diffraction peaks at diffraction angles 2θ(°) as measured by X-ray powder diffractmetry.
  
  Patent expiration dates:
  • October 26, 2026
    
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    Patent use: TREATMENT OF HIV INFECTION
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• Modulators of pharmacokinetic properties of therapeutics
  Patent 8,148,374
  Issued: April 3, 2012
  Inventor(s): Desai; Manoj C. & Liu; Hongtao & Xu; Lianhong
  Assignee(s): Gilead Sciences, Inc.
  The present application provides for a compound of Formula IV, or a pharmaceutically acceptable salt, solvate, and/or ester thereof, compositions containing such compounds, therapeutic methods that include the administration of such compounds, and therapeutic methods and include the administration of such compounds with at least one additional therapeutic agent.
  
  Patent expiration dates:
  • September 3, 2029
    
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    Patent use: TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
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• 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 INFECTION
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• Combination therapy
  Patent 8,633,219
  Issued: January 21, 2014
  Assignee(s): Japan Tobacco Inc.
  The present invention relates to a combination therapy for treating an HIV infection or inhibiting integrase comprising (S)-6-(3-Chloro-2-fluorobenzyl)-1-(1-hydroxymethyl-2-methylpropyl)-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (“Compound A”) or a pharmaceutically acceptable solvate or salt thereof in combination with at least one other anti-HIV agent. In some embodiments of the present invention, the other anti-HIV agents are chosen from reverse transcriptase inhibitors and protease inhibitors. In certain embodiments of the present invention, the other anti-HIV agents are chosen from AZT, 3TC, PMPA, efavirenz, indinavir, nelfinavir, a combination of AZT/3TC, and a combination of PMPA/3TC. Since Compound A has a high inhibitory activity specific for integrases, when used in combinations with other anti-HIV agents it can provide a combination therapy with fewer side effects for humans.
  
  Patent expiration dates:
  • April 24, 2030
    
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    Patent use: TREATMENT OF HIV INFECTION
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• 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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• Stable crystal of 4-oxoquinoline compound
  Patent 8,981,103
  Issued: March 17, 2015
  Assignee(s): Japan Tobacco Inc.
  Provision of a stabilized crystal of 6-(3-chloro-2-fluorobenzyl)-1-[(S)-1-hydroxymethyl-2-methylpropyl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (compound A). A crystal of compound A, which shows a particular X-ray powder diffraction pattern of a characteristic diffraction peaks at diffraction angles 2θ(°) as measured by X-ray powder diffractometry.
  
  Patent expiration dates:
  • October 26, 2026
    
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• Compositions and methods for combination antiviral therapy
  Patent 9,457,036
  Issued: October 4, 2016
  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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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:
  • August 27, 2017 - NEW CHEMICAL ENTITY
  • December 17, 2017 - EXPANDED INDICATION TO INCLUDE PATIENTS WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA <50 COPIES/ML) ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TREATMENT FAILURE IN ORDER TO REPLACE THEIR CURRENT REGIMEN
  • January 27, 2020 - NEW PATIENT POPULATION