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Last Updated: November 7, 2024

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 two branded drugs marketed by Hetero Labs Ltd V and Metuchen Pharms, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Avanafil has forty-one patent family members in twenty-five countries.

There are five drug master file entries for avanafil. Two suppliers are listed for this compound.

Summary 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

Pharmacology for AVANAFIL
Paragraph IV (Patent) Challenges for AVANAFIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STENDRA Tablets avanafil 50 mg, 100 mg and 200 mg 202276 1 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 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V AVANAFIL avanafil TABLET;ORAL 209266-003 Jun 14, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AVANAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 ⤷  Sign Up ⤷  Sign Up
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 ⤷  Sign Up ⤷  Sign Up
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for AVANAFIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Menarini International Operations Luxembourg S.A. Spedra avanafil EMEA/H/C/002581
Treatment of erectile dysfunction in adult men.In order for Spedra to be effective, sexual stimulation is required.
Authorised no no no 2013-06-21 2013-04-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for AVANAFIL

Country Patent Number Title Estimated Expiration
Spain 2283315 ⤷  Sign Up
Russian Federation 2233273 АРОМАТИЧЕСКИЕ АЗОТСОДЕРЖАЩИЕ 6-ЧЛЕННЫЕ ЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ⤷  Sign Up
Bulgaria 106566 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AVANAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 122013000096 Germany ⤷  Sign Up PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 C300618 Netherlands ⤷  Sign Up PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 C01219609/01 Switzerland ⤷  Sign Up PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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