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Last Updated: August 8, 2020

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.

US ANDA Litigation and 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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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   Start Trial   Start Trial Y Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>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 2013C/051 Belgium   Start Trial PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609 2013/041 Ireland   Start Trial PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609 92249 Luxembourg   Start Trial PRODUCT NAME: AVANAFIL
1219609 SPC/GB13/071 United Kingdom   Start Trial PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
1219609 13C0050 France   Start Trial PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 C300618 Netherlands   Start Trial PRODUCT NAME: AVANAFIL; REGISTRATION 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.