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STENDRA Drug Profile

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Stendra is a drug marketed by Metuchen Pharms and is included in one NDA. It is available from one supplier. 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. One supplier is 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 list1
Drug Prices: :see details

Pharmacology for Tradename: STENDRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXNo6,656,935► subscribeYY ► subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-002Apr 27, 2012RXNo► subscribe► subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXNo► 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
7,273,868Pyrazine derivatives► subscribe
7,220,736Pyrimidine compounds► 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
Hungary0202795► subscribe
China1462193► subscribe
Australia7311800► 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
90047-7Sweden► subscribePRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
249Luxembourg► subscribePRODUCT NAME: AVANAFIL
00618Netherlands► subscribePRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
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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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