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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Healthtrust
Argus Health
Farmers Insurance
Julphar
Deloitte
AstraZeneca
QuintilesIMS
Accenture

Generated: December 14, 2018

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STENDRA Drug Profile

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Which patents cover Stendra, and what generic alternatives 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-five 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.

Drug patent expirations by year for STENDRA
Generic Entry Opportunity Date for STENDRA
Generic Entry Date for STENDRA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for STENDRA
Synonyms for STENDRA
(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
330785-17-6
4-((3-Chloro-4-methoxybenzyl)amino)-2-((2S)-2-(hydroxymethyl)pyrrolidin-1-yl)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide
4-[(3-chloro-4-methoxy-phenyl)methylamino]-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
4-[[(3-Chloro-4-methoxyphenyl)methyl]amino]-2-[(2S)-2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide
5-Pyrimidinecarboxamide, 4-(((3-chloro-4-methoxyphenyl)methyl)amino)-2-((2S)-2-(hydroxymethyl)-1-pyrrolidinyl)-N-(2-pyrimidinylmethyl)-
647841-09-6
AB01565827_02
AJ-126296
AK161455
AKOS024462448
AMX10164
AN-28849
API0007039
AS-20106
Avanafil
Avanafil (USAN/INN)
Avanafil [USAN:INN]
Avanafil; 4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide; (S)-2-(2-Hydroxymethyl-1-pyrrolidinyl)-4-(3-chloro-4-methoxybenzylamino)-5-[(2-pyrimidinylmet
AX8294388
BDBM50036629
BRD-K65781196-001-01-4
CCG-229896
CHEBI:66876
CHEMBL1963681
CS-2644
D03217
D0Y5JC
DB06237
DR5S136IVO
DTXSID50186727
GTPL7448
HE070053
HY-18252
J-019006
KS-0000028R
MFCD11977961
MolPort-029-944-565
PB28365
Q-4413
RL03196
s4019
SCHEMBL118799
Spedra
Spedra (TN)
ST24036163
Stendra (TN)
TA 1790
TA-1790
UNII-DR5S136IVO
VI-0162
WEAJZXNPAWBCOA-INIZCTEOSA-N
Zepeed
ZINC11677857

US Patents and Regulatory Information for STENDRA

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 202276-001 Apr 27, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Paragraph IV (Patent) Challenges for STENDRA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 50 mg, 100 mg and 200 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for STENDRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00618 Netherlands ➤ Sign Up PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
C0050 France ➤ Sign Up PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
6 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
AstraZeneca
Boehringer Ingelheim
Medtronic
Baxter
Colorcon
Daiichi Sankyo
Argus Health

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