EMTRICITABINE Drug Patent Profile

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Emtricitabine is a drug marketed by Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Apotex, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms. and is included in sixteen NDAs.

The generic ingredient in EMTRICITABINE is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.

A generic version of EMTRICITABINE was approved as emtricitabine; tenofovir alafenamide fumarate by APOTEX on May 17^th, 2024.

US Patents:	0
Applicants:	13
NDAs:	16
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	505
Patent Applications:	5,430
Drug Prices:	Drug price information for EMTRICITABINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE
DailyMed Link:	EMTRICITABINE at DailyMed

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Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
King's College London	Phase 3
Wits Health Consortium (Pty) Ltd	Phase 3

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Anti-HIV Agents
Antiviral Agents
Reverse Transcriptase Inhibitors

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMTRIVA	Capsules	emtricitabine	200 mg	021500	1	2012-07-16

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	EMTRICITABINE	emtricitabine	CAPSULE;ORAL	079188-001	Mar 15, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203442-001	May 15, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	212689-004	Jul 1, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-002	Aug 22, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	214053-001	May 17, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	211640-001	Mar 9, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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