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Last Updated: October 1, 2022

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 are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in twenty-six 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 April 27, 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

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for STENDRA
Generic Entry Date for STENDRA*:
Constraining patent/regulatory exclusivity:
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 two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STENDRA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ERECTILE DYSFUNCTION

Preparations for oral administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 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
Austria 358670 See Plans and Pricing
Israel 148291 AROMATIC NITROGEN-CONTAINING 6-MEMBERED CYCLIC COMPOUNDS See Plans and Pricing
Bulgaria 106566 See Plans and Pricing
Brazil PI0014526 compostos cíclicos de seis elementos contendo nitrogênio aromático, composição farmacêutica e uso do mesmo See Plans and Pricing
South Korea 100610131 See Plans and Pricing
Taiwan I258471 See Plans and Pricing
Canada 2383466 COMPOSES CYCLIQUES AROMATIQUES AZOTES A SIX ELEMENTS (AROMATIC NITROGEN-CONTAINING 6-MEMBERED CYCLIC COMPOUNDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STENDRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 CA 2013 00040 Denmark See Plans and Pricing
1219609 122013000096 Germany See Plans and Pricing PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 SPC/GB13/071 United Kingdom See Plans and Pricing PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
1219609 2013/041 Ireland See Plans and Pricing PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609 C01219609/01 Switzerland See Plans and Pricing PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016
1219609 92249 Luxembourg See Plans and Pricing PRODUCT NAME: AVANAFIL
1219609 1390047-7 Sweden See Plans and Pricing PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Mallinckrodt
Baxter
Boehringer Ingelheim
Merck

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.