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Last Updated: March 28, 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 one branded drug marketed by Metuchen Pharms and is included in one NDA. 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. One supplier is listed for this compound.

Summary for AVANAFIL
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AVANAFIL
Generic Entry Date for AVANAFIL*:
Constraining patent/regulatory exclusivity:
REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY
Dosage:
TABLET;ORAL

*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 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 202276-003 Apr 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 ⤷  Try a Trial ⤷  Try a Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 ⤷  Try a Trial ⤷  Try a Trial
>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

Supplementary Protection Certificates for AVANAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 2013/041 Ireland ⤷  Try a Trial PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609 C300618 Netherlands ⤷  Try a Trial PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 CA 2013 00040 Denmark ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.