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Last Updated: November 7, 2024

AVANAFIL Drug Patent Profile


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When do Avanafil patents expire, and when can generic versions of Avanafil launch?

Avanafil is a drug marketed by Hetero Labs Ltd V and is included in one NDA.

The generic ingredient in AVANAFIL is avanafil. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Avanafil

A generic version of AVANAFIL was approved as avanafil by HETERO LABS LTD V on June 14th, 2024.

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Drug patent expirations by year for AVANAFIL
Recent Clinical Trials for AVANAFIL

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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
Hetero Labs Ltd V AVANAFIL avanafil TABLET;ORAL 209266-001 Jun 14, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V AVANAFIL avanafil TABLET;ORAL 209266-002 Jun 14, 2024 AB RX No 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

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