Generic Atripla Availability

Posted by glbgn754 on July 17, 2014
Uncategorized

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

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

Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
September 2, 2014

Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
March 2, 2015

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

Drug substance

Drug product
March 29, 2016

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

Drug substance
January 2, 2018

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

Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Drug substance
July 25, 2017

Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Drug substance
January 25, 2018

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

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

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

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

Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
January 25, 2018

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
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

Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
November 4, 2020

Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
May 4, 2021

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

Drug substance

Drug product
September 9, 2021

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
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

Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Drug product
January 13, 2024

Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS

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

Drug product

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