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 |
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
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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