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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Julphar
Teva
McKesson
Accenture
Deloitte
Healthtrust
AstraZeneca
Mallinckrodt
Chinese Patent Office

Generated: January 21, 2018

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-five 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 avanafil
International Patents:55
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 5
Suppliers / Packagers: 1
Bulk Api Vendors: 48
Clinical Trials: 23
Patent Applications: 1,012
Drug Prices:see low prices
DailyMed Link:avanafil at DailyMed
Pharmacology for avanafil

US Patents and Regulatory Information for 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;ORAL 202276-003 Apr 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,220,736 Pyrimidine compounds ➤ Subscribe
7,273,868 Pyrazine derivatives ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for avanafil

Supplementary Protection Certificates for avanafil

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
249 Luxembourg ➤ Subscribe PRODUCT NAME: AVANAFIL
2013000096 Germany ➤ Subscribe PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
C0050 France ➤ Subscribe PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
2013 00040 Denmark ➤ Subscribe
13/041 Ireland ➤ Subscribe PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
00618 Netherlands ➤ Subscribe PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
90047-7 Sweden ➤ Subscribe PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
6 Finland ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Deloitte
Cipla
Fish and Richardson
Boehringer Ingelheim
Daiichi Sankyo
Fuji
Queensland Health
Argus Health
Novartis

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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