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Last Updated: August 3, 2020

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AVANAFIL - Generic Drug Details

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What are the generic drug sources for avanafil and what is the scope of freedom to operate?

Avanafil is the generic ingredient in one branded drug marketed by Metuchen Pharms and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Avanafil has fifty-five patent family members in twenty-six countries.

There are five drug master file entries for avanafil.

Recent Clinical Trials for AVANAFIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of AlexandriaPhase 4
Astellas Pharma US, Inc.Phase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2

See all AVANAFIL clinical trials

Paragraph IV (Patent) Challenges for AVANAFIL
Tradename Dosage Ingredient NDA Submissiondate
STENDRA TABLET;ORAL avanafil 202276 2016-04-27

US Patents and Regulatory Information for AVANAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for AVANAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 C01219609/01 Switzerland   Start Trial PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016
1219609 2013C/051 Belgium   Start Trial PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609 13C0050 France   Start Trial PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 CA 2013 00040 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Dow
Baxter
Mallinckrodt
Merck

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