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Generated: February 21, 2019

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STENDRA Drug Profile

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When do Stendra patents expire, and when can generic versions of Stendra launch?

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 ➤ Sign Up
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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 202276-003 Apr 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 RX Yes Yes ➤ 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
C0050 France ➤ Sign Up PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
00618 Netherlands ➤ Sign Up PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
13/041 Ireland ➤ Sign Up PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
2013000096 Germany ➤ Sign Up PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
2013 00040 Denmark ➤ Sign Up
90047-7 Sweden ➤ Sign Up PRODUCT NAME: AVANAFIL; REG. 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:

Queensland Health
Moodys
Daiichi Sankyo
Julphar
Chinese Patent Office
McKesson
Cantor Fitzgerald
Federal Trade Commission
US Army

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.