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 twenty 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:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	18
Patent Applications:	194
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for revefenacin
What excipients (inactive ingredients) are in revefenacin?	revefenacin excipients list
DailyMed Link:	revefenacin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for revefenacin

Generic Entry Date for revefenacin^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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

Anatomical Therapeutic Chemical (ATC) Classes for revefenacin

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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	Y	Y		⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Japan	2008532922		⤷ Sign Up
Slovenia	2453894		⤷ Sign Up
European Patent Office	1930323	Composés biphényle convenant pour la préparation d'antagonistes du récepteur muscarinique (Biphenyl compounds useful in the synthesis of muscarinic receptor antagonists)	⤷ Sign Up
Singapore	10201407913U	CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND	⤷ Sign Up
Austria	E467617		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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