EMTRICITABINE - Generic Drug Details

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What are the generic sources for emtricitabine and what is the scope of patent protection?

Emtricitabine is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma Ltd, Cipla, Gilead, Gilead Sciences Inc, Apotex, Hetero Labs Ltd Iii, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-two NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for emtricitabine. Three suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for EMTRICITABINE

US Patents:	10
Tradenames:	9
Applicants:	15
NDAs:	22
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	505
Patent Applications:	5,980
Drug Prices:	Drug price trends for EMTRICITABINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE
What excipients (inactive ingredients) are in EMTRICITABINE?	EMTRICITABINE excipients list
DailyMed Link:	EMTRICITABINE at DailyMed

See drug prices for EMTRICITABINE

Recent Clinical Trials for EMTRICITABINE

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

Sponsor	Phase
Ministry of Health, Uganda	Phase 3
Assistance Publique - Hôpitaux de Paris	Phase 3
King's College London	Phase 3

See all EMTRICITABINE clinical trials

Generic filers with tentative approvals for EMTRICITABINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MG; 300MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	200MG	CAPSULE; ORAL
⤷ Sign Up	⤷ Sign Up	200MG;300MG;200MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for EMTRICITABINE

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

Medical Subject Heading (MeSH) Categories for EMTRICITABINE

Anti-HIV Agents
Antiviral Agents
Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMTRICITABINE

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

Paragraph IV (Patent) Challenges for EMTRICITABINE

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

US Patents and Regulatory Information for EMTRICITABINE

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Glossary

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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
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-001	Aug 22, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	211640-002	Mar 9, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mylan	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	206436-001	Apr 9, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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 EMTRICITABINE

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

EU/EMA Drug Approvals for EMTRICITABINE

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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

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