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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Fuji
Chubb
Cipla
Argus Health
Harvard Business School
Medtronic
Cerilliant

Generated: May 22, 2018

DrugPatentWatch Database Preview

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
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
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y 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 Submissiondate
➤ Subscribe Tablets 50 mg, 100 mg and 200 mg ➤ Subscribe 2016-04-27

Non-Orange Book US Patents for STENDRA

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
7,273,868 Pyrazine derivatives ➤ Sign Up
6,797,709 Aromatic nitrogen-containing 6-membered cyclic compounds ➤ Sign Up
7,220,736 Pyrimidine compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for STENDRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90047-7 Sweden ➤ Sign Up PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
6 Finland ➤ Sign Up
249 Luxembourg ➤ Sign Up PRODUCT NAME: AVANAFIL
00618 Netherlands ➤ Sign Up PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Merck
Citi
Accenture
UBS
Julphar
Farmers Insurance
US Department of Justice
Daiichi Sankyo

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.