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Last Updated: March 29, 2024

EMTRIVA Drug Patent Profile


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Which patents cover Emtriva, and when can generic versions of Emtriva launch?

Emtriva is a drug marketed by Gilead and is included in two NDAs.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Emtriva

A generic version of EMTRIVA was approved as emtricitabine by CIPLA on July 2nd, 2018.

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Drug patent expirations by year for EMTRIVA
Drug Prices for EMTRIVA

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Recent Clinical Trials for EMTRIVA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Brown UniversityPhase 1
Butler HospitalPhase 1
Alzheimer's AssociationPhase 1

See all EMTRIVA clinical trials

Paragraph IV (Patent) Challenges for EMTRIVA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EMTRIVA Capsules emtricitabine 200 mg 021500 1 2012-07-16

US Patents and Regulatory Information for EMTRIVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EMTRIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ⤷  Try a Trial ⤷  Try a Trial
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ⤷  Try a Trial ⤷  Try a Trial
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for EMTRIVA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Emtriva emtricitabine EMEA/H/C/000533
Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.
Authorised no no no 2003-10-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for EMTRIVA

See the table below for patents covering EMTRIVA around the world.

Country Patent Number Title Estimated Expiration
Australia 4031995 ⤷  Try a Trial
Canada 2105486 NUCLEOSIDES THERAPEUTIQUES (THERAPEUTIC NUCLEOSIDES) ⤷  Try a Trial
Norway 20065640 ⤷  Try a Trial
Romania 108564 DERIVATI DE NUCLEOZIDE, PROCEDEU DE OBTINERE A LOR SI INTERMEDIARI PENTRU ACESTIA (NUCLEOSIDASE DERIVATES, PREPARATION PROCESS AND INTERMEDIARIES THEREFOR) ⤷  Try a Trial
Australia 665187 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMTRIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 15C0071 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
3150586 132020000000055 Italy ⤷  Try a Trial PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925
1663240 2015/053 Ireland ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240 1590057-4 Sweden ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
0915894 SPC/GB08/033 United Kingdom ⤷  Try a Trial PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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