STENDRA Drug Patent Profile
✉ Email this page to a colleague
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
Summary for STENDRA
| International Patents: | 41 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,843 |
| 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 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
| Sponsor | Phase |
|---|---|
| VIVUS, Inc. | Phase 4 |
| VIVUS, Inc. | Phase 3 |
Pharmacology for STENDRA
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for STENDRA
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 | ||
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-003 | Apr 27, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-003 | Apr 27, 2012 | RX | Yes | Yes | ⤷ 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 | 202276-003 | 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 |
| >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 |
|---|---|---|---|
| Brazil | PI0014526 | compostos cíclicos de seis elementos contendo nitrogênio aromático, composição farmacêutica e uso do mesmo | ⤷ Try a Trial |
| Canada | 2420461 | PREPARATIONS ADMINISTREES PAR VOIE ORALE (PREPARATIONS FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
| Japan | 4588973 | ⤷ Try a Trial | |
| Hungary | 225917 | PYRIMIDINE AND PYRAZINE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE | ⤷ Try a Trial |
| South Korea | 100610131 | ⤷ Try a Trial | |
| European Patent Office | 1219609 | COMPOSES CYCLIQUES AROMATIQUES AZOTES A SIX ELEMENTS (AROMATIC NITROGENOUS SIX-MEMBERED RING COMPOUNDS) | ⤷ Try a Trial |
| Norway | 2013018 | ⤷ 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 | SPC/GB13/071 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621 |
| 1219609 | 1390047-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621 |
| 1219609 | 92249 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AVANAFIL |
| 1219609 | C300618 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621 |
| 1219609 | C01219609/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016 |
| 1219609 | 13C0050 | France | ⤷ Try a Trial | PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621 |
| 1219609 | 122013000096 | Germany | ⤷ Try a Trial | PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
