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Last Updated: February 29, 2024

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 nineteen 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for revefenacin
Generic Entry Date for revefenacin*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for revefenacin

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

SponsorPhase
Mylan Inc.Phase 4
Theravance BiopharmaPhase 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 1723114 COMPOSES BIPHENYLE CONVENANT COMME ANTAGONISTES DU RECEPTEUR MUSCARINIQUE (BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS) ⤷  Try a Trial
Taiwan 202019389 Methods for treating chronic obstructive pulmonary disease ⤷  Try a Trial
Japan 2008532922 ⤷  Try a Trial
Morocco 28524 COMPOSES BIPHENYLE CONVENANT COMME ANTAGONISTES DU RECEPTEUR MUSCARINIQUE ⤷  Try a Trial
Denmark 1723114 ⤷  Try a Trial
Germany 602005021258 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.