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*:
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
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 |
Anatomical Therapeutic Chemical (ATC) Classes for revefenacin
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 | ⤷ 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 | ⤷ 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 | |||
>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 |
---|---|---|---|
South Korea | 20130027004 | CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND | ⤷ Sign Up |
Portugal | 1723114 | ⤷ Sign Up | |
Croatia | P20151344 | ⤷ Sign Up | |
Singapore | 178036 | CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND | ⤷ Sign Up |
Denmark | 2453894 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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