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

Sponsor	Phase
Theravance Biopharma	Phase 4
Mylan Inc.	Phase 4
Mylan Pharmaceuticals	Phase 1

See all revefenacin clinical trials

Pharmacology for revefenacin

Drug Class	Anticholinergic
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

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Glossary

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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

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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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