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Last Updated: July 5, 2020

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Efavirenz - Generic Drug Details

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

Efavirenz is the generic ingredient in seven branded drugs marketed by Aurobindo Pharma Ltd, Bristol Myers Squibb, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Gilead Sciences, Teva Pharms Usa, Macleods Pharms Ltd, and Mylan Labs Ltd, and is included in seventeen NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for efavirenz. Eight suppliers are listed for this compound. There are twenty-one tentative approvals for this compound.

Drug Prices for efavirenz

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Recent Clinical Trials for efavirenz

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SponsorPhase
Allergan, plcPhase 2
Idorsia Pharmaceuticals Ltd.Phase 1
HeNan Sincere Biotech Co., LtdPhase 3

See all efavirenz clinical trials

Generic filers with tentative approvals for EFAVIRENZ
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET; ORAL
  Start Trial  Start Trial200MGTABLET; ORAL
  Start Trial  Start Trial100MGTABLET; ORAL

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

Paragraph IV (Patent) Challenges for EFAVIRENZ
Tradename Dosage Ingredient NDA Submissiondate
SUSTIVA CAPSULE;ORAL efavirenz 020972 2016-11-03
SUSTIVA TABLET;ORAL efavirenz 021360 2009-04-09

US Patents and Regulatory Information for efavirenz

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-002 Feb 1, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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 efavirenz

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002   Start Trial   Start Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-002 Feb 1, 2002   Start Trial   Start Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Colorcon
AstraZeneca
Dow
Johnson and Johnson

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.