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Last Updated: March 30, 2023

Revefenacin - Generic Drug Details


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What are the generic sources for revefenacin and what is the scope of freedom to operate?

Revefenacin is the generic ingredient in one branded drug marketed by Mylan Ireland Ltd and is included in one NDA. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Revefenacin has seventy-three patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for revefenacin
Recent Clinical Trials for revefenacin

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

SponsorPhase
Theravance BiopharmaPhase 4
Mylan Inc.Phase 4
Mylan PharmaceuticalsPhase 1

See all revefenacin clinical trials

Pharmacology for revefenacin
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Paragraph IV (Patent) Challenges for REVEFENACIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
YUPELRI Inhalation Solution revefenacin 175 mcg/3 mL 210598 7 2022-11-09

US Patents and Regulatory Information for revefenacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  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

International Patents for revefenacin

Country Patent Number Title Estimated Expiration
Cyprus 1109015 ⤷  Sign Up
Malaysia 144482 BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS ⤷  Sign Up
Slovenia 2453894 ⤷  Sign Up
European Patent Office 2453894 FORME CRISTALLINE D'UNE BASE LIBRE D'UNE COMPOSE DE BIPHENYLE (CRYSTALLINE FREEBASE FORM OF A BIPHENYL COMPOUND) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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