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 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
*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 |
|---|---|
| Mylan Inc. | Phase 4 |
| Theravance Biopharma | 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 | ⤷ 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 | ⤷ 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 | ⤷ 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 |
|---|---|---|---|
| Canada | 2989129 | FORMES A BASE LIBRE CRISTALLINE D'UN COMPOSE BIPHENYLE (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND) | ⤷ Sign Up |
| Spain | 2639642 | ⤷ Sign Up | |
| Poland | 2453894 | ⤷ Sign Up | |
| Spain | 2345640 | ⤷ Sign Up | |
| Norway | 20064579 | ⤷ Sign Up | |
| Argentina | 104444 | DERIVADO DE ÁCIDO BIFENIL CARBÁMICO Y SUS SALES | ⤷ Sign Up |
| Slovenia | 2453894 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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