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Last Updated: May 30, 2020

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Avanafil - Generic Drug Details

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What are the generic drug sources for avanafil and what is the scope of patent protection?

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.

Recent Clinical Trials for avanafil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Astellas Pharma US, Inc.Phase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2
SanofiPhase 3

See all avanafil clinical trials

Recent Litigation for avanafil

Identify potential future generic entrants

District Court Litigation
Case NameDate
VIVUS, INC. v. HETERO USA, INC.2016-07-27

See all avanafil litigation

Synonyms for avanafil
(S)-2-(2-Hydroxymethyl-1-pyrrolidinyl)-4-(3-chloro-4-methoxybenzylamino)-5-[(2-pyrimidinylmethyl)carbamoyl]pyrimidine
(S)-2-(2-hydroxymethyl-1-pyrrolidinyl)-4-(3-chloro-4-methoxybenzylamino)-5-[N-(2-pyrimidylmethyl)carbamoyl]-pyrimidine
(S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide
(S)-4-(3-Chloro-4-methoxybenzylamino)-2-(2-hydroxymethylpyrrolidin-1-yl)-N-pyrimidin-2-ylmethyl-5-pyrimidinecarboxamide
(S)-4-[(3-Chlor-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1- pyrrolidinyl]-N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamid
330784-47-9
4-((3-Chloro-4-methoxybenzyl)amino)-2-((2S)-2-(hydroxymethyl)pyrrolidin-1-yl)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide
4-[(3-chloro-4-methoxybenzyl)amino]-2-[(2S)-2-(hydroxymethyl)pyrrolidin-1-yl]-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide
4-[(3-chloro-4-methoxyphenyl)methylamino]-2-[(2S)-2-(hydroxymethyl)pyrrolidin-1-yl]-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide
5-Pyrimidinecarboxamide, 4-(((3-chloro-4-methoxyphenyl)methyl)amino)-2-((2S)-2-(hydroxymethyl)-1-pyrrolidinyl)-N-(2-pyrimidinylmethyl)-
AB01565827_02
AKOS024462448
AMX10164
API0007039
AS-20106
Avanafil (USAN/INN)
Avanafil [USAN:INN]
Avanafil; (S)-4-chloro-6-((3-chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide
AX8294388
BDBM50036629
BRD-K65781196-001-01-4
CCG-229896
CHEBI:66876
CHEMBL1963681
CS-2644
D03217
DB06237
DR5S136IVO
DTXSID50186727
GTPL7448
HY-18252
J-019006
KS-0000028R
OR302290
PB28365
Q-4413
Q2873270
s4019
SCHEMBL118799
Spedra
Spedra (TN)
ST24036163
STENDRA
Stendra (TN)
SW219217-1
TA 1790
TA-1790
UNII-DR5S136IVO
VI-0162
WEAJZXNPAWBCOA-INIZCTEOSA-N
Zepeed
ZINC11677857
Paragraph IV (Patent) Challenges for AVANAFIL
Tradename Dosage Ingredient NDA Submissiondate
STENDRA TABLET;ORAL avanafil 202276 2016-04-27

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 202276-002 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for avanafil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 C300618 Netherlands   Start Trial PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 2013C/051 Belgium   Start Trial PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609 CA 2013 00040 Denmark   Start Trial
1219609 122013000096 Germany   Start Trial PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 92249 Luxembourg   Start Trial PRODUCT NAME: AVANAFIL
1219609 SPC/GB13/071 United Kingdom   Start Trial PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
Dow
AstraZeneca
Mallinckrodt
Moodys

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.