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Last Updated: June 25, 2021

DrugPatentWatch Database Preview

STENDRA Drug 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. 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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Summary for STENDRA
Drug patent expirations by year for STENDRA
Drug Prices for STENDRA

See drug prices for STENDRA

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

Paragraph IV (Patent) Challenges for STENDRA
Tradename Dosage Ingredient NDA Submissiondate
STENDRA TABLET;ORAL avanafil 202276 2016-04-27

US Patents and Regulatory Information for STENDRA

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   Get Started Free   Get Started Free Y Y   Get Started Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for STENDRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 SPC/GB13/071 United Kingdom   Get Started Free PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
1219609 C01219609/01 Switzerland   Get Started Free PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016
1219609 122013000096 Germany   Get Started Free PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 CA 2013 00040 Denmark   Get Started Free
1219609 1390047-7 Sweden   Get Started Free PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
1219609 476 Finland   Get Started Free
>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

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