Generic Atripla Availability
Last updated on Mar 13, 2025.
Atripla is a brand name of efavirenz/emtricitabine/tenofovir disoproxil, approved by the FDA in the following formulation(s):
ATRIPLA (efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet;oral)
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Manufacturer: GILEAD SCIENCES
Approval date: July 12, 2006
Strength(s): 600MG;200MG;300MG (discontinued) [RLD] [AB]
All of the above formulations have been discontinued.
Has a generic version of Atripla been approved?
A generic version of Atripla 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 Atripla and have been approved by the FDA:
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (efavirenz; emtricitabine; tenofovir disoproxil fumarate tablet;oral)
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Manufacturer: AUROBINDO PHARMA
Approval date: September 4, 2018
Strength(s): 600MG;200MG;300MG [AB] -
Manufacturer: CIPLA
Approval date: June 3, 2019
Strength(s): 600MG;200MG;300MG [AB] -
Manufacturer: HETERO LABS LTD V
Approval date: January 24, 2022
Strength(s): 600MG;200MG;300MG [AB] -
Manufacturer: LAURUS
Approval date: December 22, 2021
Strength(s): 600MG;200MG;300MG [AB] -
Manufacturer: MACLEODS PHARMS LTD
Approval date: September 13, 2021
Strength(s): 600MG;200MG;300MG [AB] -
Manufacturer: TEVA PHARMS USA
Approval date: November 9, 2018
Strength(s): 600MG;200MG;300MG [AB]
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: Generic Drug FAQ.
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.
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Unitary pharmaceutical dosage form
Patent 8,598,185
Issued: December 3, 2013
Inventor(s): Dahl Terrence C. & Hussain Munir A. & Lipper Robert A. & Jerzewski Robert L. & Menning Mark M. & Oliyai Reza & Yang Taiyin
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:
- April 28, 2029✓
- April 28, 2029
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Unitary pharmaceutical dosage form
Patent 9,018,192
Issued: April 28, 2015
Inventor(s): Dahl Terrence C. & Hussain Munir A. & Lipper Robert A. & Jerzewski Robert L. & Menning Mark M. & Oliyai Reza & Yang Taiyin
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 comprising tenofovir DF (and, optionally, emtricitabine) and component comprising efavirenz, wherein components and are in a stabilizing configuration. In preferred embodiments component is made by dry granulation.
Patent expiration dates:
- June 13, 2026✓
- June 13, 2026✓
- June 13, 2026
-
Unitary pharmaceutical dosage form
Patent 9,545,414
Issued: January 17, 2017
Inventor(s): Dahl Terrence C. & Hussain Munir A. & Lipper Robert A. & Jerzewski Robert L. & Menning Mark M. & Oliyai Reza & Yang Taiyin
Assignee(s): BRISTOL-MYERS SQUIBB & GILEAD SCIENCES, LLCIn 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:
- June 13, 2026✓✓
- June 13, 2026✓✓
- June 13, 2026
More about Atripla (efavirenz / emtricitabine / tenofovir disoproxil)
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- Drug class: antiviral combinations
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Glossary
Term | Definition |
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Drug Patent | A 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 Exclusivity | Exclusivity 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. |
RLD | A 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. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.