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Serving 500+ biopharmaceutical companies globally:

Citi
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Johnson and Johnson
Healthtrust
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Novartis
Moodys
Farmers Insurance
Teva
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Generated: September 22, 2017

DrugPatentWatch Database Preview

Avanafil - Generic Drug Details

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What are the generic drug sources for avanafil and what is the scope of avanafil freedom to operate?

Avanafil
is the generic ingredient in one branded drug marketed by Metuchen Pharms and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Avanafil has fifty-three patent family members in twenty-six countries.

There are five drug master file entries for avanafil. One supplier is listed for this compound.

Summary for Generic Name: avanafil

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list1
Bulk Api Vendors: see list38
Clinical Trials: see list23
Patent Applications: see list909
Drug Prices:see low prices
DailyMed Link:avanafil at DailyMed

Pharmacology for Ingredient: avanafil

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;ORAL202276-002Apr 27, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-002Apr 27, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-003Apr 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-003Apr 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-002Apr 27, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-003Apr 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Metuchen Pharms
STENDRA
avanafil
TABLET;ORAL202276-001Apr 27, 2012RXYesNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: avanafil

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 Ingredient: avanafil

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0183460► Subscribe
Norway2013018► Subscribe
China1657523► Subscribe
Austria358670► Subscribe
New Zealand524572► Subscribe
China1374953► Subscribe
European Patent Office1277741► Subscribe
Hungary0202795► Subscribe
Spain2381862► Subscribe
Israel148291► 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: AVANAFIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/041Ireland► SubscribePRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
249Luxembourg► SubscribePRODUCT NAME: AVANAFIL
2013000096Germany► SubscribePRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
00618Netherlands► SubscribePRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
6Finland► Subscribe
2013 00040Denmark► Subscribe
C0050France► SubscribePRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
90047-7Sweden► SubscribePRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Harvard Business School
Fuji
Accenture
AstraZeneca
Merck
Express Scripts
Johnson and Johnson
Chinese Patent Office

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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