Tuesday 13 September 2016

Complera


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


COMPLERA (emtricitabine; rilpivirine; tenofovir disoproxil fumarate - tablet; oral)



  • Manufacturer: GILEAD SCIENCES INC

    Approval date: August 10, 2011

    Strength(s): 200MG;25MG;300MG [RLD]

Has a generic version of Complera been approved?


No. There is currently no therapeutically equivalent version of Complera available.


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




  • 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 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 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 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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      Drug substance
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      Drug product


    • January 25, 2018
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      Patent use: TREATMENT OF HIV INFECTION
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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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      Drug substance
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      Drug product


    • September 9, 2021
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      Pediatric exclusivity




  • 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents
    Patent 6,838,464
    Issued: January 4, 2005
    Inventor(s): Pease; Elizabeth Janet & Williams; Emma Jane & Bradbury; Robert Hugh & Pearson; Stuart Eric
    Assignee(s): AstraZeneca AB
    Pyrimidine derivatives of formula (I) wherein Q1, Q2, G and R1 are as defined within; and pharmaceutically acceptable salts and in vivo hydrolysable esters thereof are described. Processes for their manufacture, pharmaceutical compositions and their use as cyclin-dependent serine/threonine kinase (CDK) and focal adhesion kinase (FAK) inhibitors are also described.
    Patent expiration dates:

    • February 26, 2021
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      Drug substance
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      Drug product




  • 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents
    Patent 7,067,522
    Issued: June 27, 2006
    Inventor(s): Pease; Elizabeth Janet & Williams; Emma Jane & Bradbury; Robert Hugh & Pearson; Stuart Eric
    Assignee(s): AstraZeneca AB
    Pyrimidine derivatives of formula (I) wherein Q1, Q2, G and R1 are as defined within; and pharmaceutically acceptable salts and in vivo hydrolysable esters thereof are described. Processes for their manufacture, pharmaceutical compositions and their use as cyclin-dependent serine/threonine kinase (CDK) and focal adhesion kinase (FAK) inhibitors are also described.
    Patent expiration dates:

    • December 20, 2019
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      Drug substance
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      Drug product




  • HIV inhibiting pyrimidines derivatives
    Patent 7,125,879
    Issued: October 24, 2006
    Inventor(s): Guillemont; Jérôme Emile Georges & Palandjian; Patrice & de Jonge; Marc René & Koymans; Lucien Maria Henricus & Vinkers; Hendrik Maarten & Daeyaert; Frederik Frans Desiré & Heeres; Jan & Van Aken; Koen Jeanne Alfons & Lewi; Paulus Joannes
    Assignee(s): Janssen Pharmaceutica N.V.
    This invention concerns HIV replication inhibitors of formula (I) the N-oxides, the pharmaceutically acceptable addition salts, the quaternary amines and the stereochemically isomeric forms thereof, wherein the ring containing −a1=a2−a3=a4—and −b1=b2−b3=b4represents pheynl, pyridyl, pyrimidinyl, pirazinyl, pyridazinyl; n is 0 to 5; m is 1 to 4; R1 is hydrogen; aryl; formyl; C1-6alkylcarbonyl; C1-6alkyl; C1-6alkyloxycarbonyl, substituted C1-6alkyl, C1-6alkylcarbonyl; R2 is hydroxy, halo, optionally substituted C1-6alkyl, C3-7cycloalkyl, optionally substituted C2-6alkenyl, optionally substituted C2-6alkynyl, C1-6alkyloxy, C1-6alkyloxycarbonyl, carboxyl, cyano, nitro, amino, mono- or di(C1-6alkyl)amino, polyhalomethyl, polyhalomethyloxy, polyhalomethylthio, —S(═O)pR6, —NH—S(═O)pR6, —C(═O)R6, —NHC(═O)H, —C(═O)NHNH?2?, —NHC(═O)R6, —C(═NH)R6 or a 5-membered hetrocycl; X1 is —NR5—, —NH—NH—, —N═N—, —O—, —C(═O)—, C1-4alkanediyl, —CHOH—, —S—, —S(═O)p—, —X2—C1-4alkanediyl- or —C1-4alkanediyl-X2—; R3 is NHR13, NR13R14; —C(═O)—NHR13; —C(═O)—NR13R14; —C(═O)—R15; —CH═N—NH—C(═O)—R16; substituted C1-6alkyl; optionally substituted C1-6alkyloxyC1-6alkyl; substituted C2-6alkenyl; substituted C2-6alkynyl; substituted C2-6alkylenyl; C1-6alkyl substituted with hydroxy and a second substituent; —C(═N—O—R8)—C1-4alkyl; R7; or —X3—R7; R4 is halo, hydroxy, C1-6alkyl, C3-7cycloalkyl, C1-6alkyloxy, cyano, nitro, polyhaloC1-6alkyl, polyhaloC1-6alkyloxy, aminocarbonyl, C1-6alkyloxycarbonyl, C1-6alkylcarbonyl, formyl, amino, mono- or di(C1-4alkyl) amino; their use as a medicine, their processes for preparation and pharmaceutical compositions comprising them
    Patent expiration dates:

    • April 14, 2023
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      Patent use: TREATMENT OF HIV INFECTION
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      Drug substance
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      Drug product



See also...

  • Complera Consumer Information (Drugs.com)
  • Complera Consumer Information (Wolters Kluwer)
  • Complera Consumer Information (Cerner Multum)
  • Emtricitabine/Rilpivirine/Tenofovir Consumer Information (Wolters Kluwer)
  • Emtricitabine, rilpivirine, and tenofovir Consumer Information (Cerner Multum)

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