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STENDRA Drug Profile

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Which patents cover Stendra, and what substitute generic drugs 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-one patent family members in twenty-six countries.

The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.

Summary for Tradename: STENDRA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list38
Clinical Trials: see list6
Patent Applications: see list509
Drug Prices:see details
DailyMed Link:STENDRA at DailyMed

Pharmacology for Tradename: STENDRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXYesNo6,656,935► SubscribeYY ► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-002Apr 27, 2012RXYesNo► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXYesNo► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-003Apr 27, 2012RXYesYes► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-002Apr 27, 2012RXYesNo► Subscribe► Subscribe
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Paragraph IV activity for: STENDRA

Drugname Dosage Strength RLD Submissiondate
avanafilTablets50 mg, 100 mg and 200 mgStendra4/27/2016

Non-Orange Book Patents for Tradename: STENDRA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,797,709 Aromatic nitrogen-containing 6-membered cyclic compounds► Subscribe
7,220,736Pyrimidine compounds► Subscribe
7,273,868Pyrazine derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: STENDRA

Country Document Number Estimated Expiration
Turkey200200701► Subscribe
European Patent Office1219609► Subscribe
World Intellectual Property Organization (WIPO)0183460► Subscribe
China1657523► Subscribe
Japan2002012587► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: STENDRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
249Luxembourg► SubscribePRODUCT NAME: AVANAFIL
C0050France► SubscribePRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
13/041Ireland► SubscribePRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
90047-7Sweden► SubscribePRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
2013 00040Denmark► Subscribe
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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 verifification 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.

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