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Last Updated: April 13, 2024

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STENDRA Drug Patent Profile


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Which patents cover Stendra, and what generic alternatives are available?

Stendra is a drug marketed by Metuchen Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch® Generic Entry Outlook for Stendra

Stendra was eligible for patent challenges on April 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 18, 2025. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for STENDRA
Drug Prices for STENDRA

See drug prices for STENDRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for STENDRA
Generic Entry Date for STENDRA*:
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
NDA:
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 STENDRA

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

SponsorPhase
VIVUS, Inc.Phase 4
VIVUS, Inc.Phase 3

See all STENDRA clinical trials

Pharmacology for STENDRA
Paragraph IV (Patent) Challenges for STENDRA
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 STENDRA

STENDRA is protected by one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STENDRA is ⤷  Try a Trial.

This potential generic entry date is based on REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting STENDRA

Aromatic nitrogen-containing 6-membered cyclic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ERECTILE DYSFUNCTION

FDA Regulatory Exclusivity protecting STENDRA

REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY
Exclusivity Expiration: ⤷  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
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
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
>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 STENDRA

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

EU/EMA Drug Approvals for STENDRA

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 STENDRA

See the table below for patents covering STENDRA around the world.

Country Patent Number Title Estimated Expiration
Taiwan I258471 ⤷  Try a Trial
European Patent Office 1219609 COMPOSES CYCLIQUES AROMATIQUES AZOTES A SIX ELEMENTS (AROMATIC NITROGENOUS SIX-MEMBERED RING COMPOUNDS) ⤷  Try a Trial
China 1374953 ⤷  Try a Trial
Australia 767558 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STENDRA

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 C01219609/01 Switzerland ⤷  Try a Trial PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016
1219609 1390047-7 Sweden ⤷  Try a Trial PRODUCT NAME: AVANAFIL; REG. 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.