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Last Updated: January 27, 2023

Revefenacin - Generic Drug Details


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

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
International Patents:73
US Patents:17
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 41
Clinical Trials: 18
Patent Applications: 201
What excipients (inactive ingredients) are in revefenacin?revefenacin excipients list
DailyMed Link:revefenacin at DailyMed
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 Action Cholinergic 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Israel 177359 BIPHENYL COMPOUNDS, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM, PROCESSES FOR THEIR PREPARATION AND USES THEREOF FOR THE PREPARATION OF MEDICAMENTS FOR ANTAGONIZING A MUSCARINIC RECEPTOR See Plans and Pricing
China 102470130 Crystalline freebase forms of a biphenyl compound See Plans and Pricing
Japan 2016026214 ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011008809 See Plans and Pricing
Morocco 28524 COMPOSES BIPHENYLE CONVENANT COMME ANTAGONISTES DU RECEPTEUR MUSCARINIQUE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
AstraZeneca
Mallinckrodt
Express Scripts
Harvard Business School

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.