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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.
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
Summary for STENDRA
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||76|
|Drug Prices:||Drug price information for STENDRA|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for STENDRA|
|What excipients (inactive ingredients) are in STENDRA?||STENDRA excipients list|
|DailyMed Link:||STENDRA at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for STENDRA
*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
|VIVUS, Inc.||Phase 4|
|VIVUS, Inc.||Phase 3|
Pharmacology 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
|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.
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|
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|
|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|