You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

EMTRICITABINE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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.

Drug Prices for EMTRICITABINE

See drug prices for EMTRICITABINE

Recent Clinical Trials for EMTRICITABINE

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

SponsorPhase
King's College LondonPhase 3
Wits Health Consortium (Pty) LtdPhase 3
Desmond Tutu HIV FoundationPhase 3

See all EMTRICITABINE clinical trials

Generic filers with tentative approvals for EMTRICITABINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up200MG; 300MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up200MGCAPSULE; ORAL
⤷  Sign Up⤷  Sign Up200MG;300MG;200MGTABLET;ORAL

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

Medical Subject Heading (MeSH) Categories for EMTRICITABINE
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-002 Jan 7, 2022 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Aurobindo Pharma EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 090513-001 Jan 26, 2018 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

Expired US Patents for EMTRICITABINE

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 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

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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.