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Last Updated: September 25, 2021

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EMTRIVA Drug Patent Profile


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When do Emtriva patents expire, and when can generic versions of Emtriva launch?

Emtriva is a drug marketed by Gilead and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-six patent family members in thirty-four countries.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Three 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

See drug prices for EMTRIVA

Recent Clinical Trials for EMTRIVA

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

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

See all EMTRIVA clinical trials

Paragraph IV (Patent) Challenges for EMTRIVA
Tradename Dosage Ingredient NDA Submissiondate
EMTRIVA CAPSULE;ORAL emtricitabine 021500 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 it Free ⤷  Try it Free ⤷  Try it Free
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 SOLUTION;ORAL 021896-001 Sep 28, 2005 ⤷  Try it Free ⤷  Try it Free
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ⤷  Try it Free ⤷  Try it Free
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for EMTRIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 2012C/022 Belgium ⤷  Try it Free PRODUCT NAME: EMTRICITABINE/RILPIVIRINE/TENOFOVIR DISOPROXIL; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001 20111128
1632232 93384 Luxembourg ⤷  Try it Free PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
0915894 SPC/GB05/041 United Kingdom ⤷  Try it Free SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Colorcon
McKesson
McKinsey
Mallinckrodt

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