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Serving leading biopharmaceutical companies globally:

US Department of Justice
Fish and Richardson
Teva
Novartis
Julphar
Fuji
Cerilliant
Accenture
Chinese Patent Office
Deloitte

Generated: November 23, 2017

DrugPatentWatch Database Preview

Tadalafil - Generic Drug Details

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

Tadalafil
is the generic ingredient in two branded drugs marketed by Eli Lilly Co and Lilly, and is included in two NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has three hundred and twenty-four patent family members in sixty-two countries and thirteen supplementary protection certificates in nine countries.

There are twenty-three drug master file entries for tadalafil. Eleven suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for tadalafil

Medical Subject Heading (MeSH) Categories for tadalafil

Tentative approvals for TADALAFIL

Applicant Application No. Strength Dosage Form
u► Subscribe20MGTABLET; ORAL
u► Subscribe20MGTABLET;ORAL
u► Subscribe10MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes► Subscribe► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo► Subscribe► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003RXYesNo► Subscribe► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXYesNo► Subscribe► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Eli Lilly Co
ADCIRCA
tadalafil
TABLET;ORAL022332-001May 22, 2009RXYesYes► Subscribe► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tadalafil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003► Subscribe► Subscribe
Eli Lilly Co
ADCIRCA
tadalafil
TABLET;ORAL022332-001May 22, 2009► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: tadalafil

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
6,451,807 Methods of treating sexual dysfunction in an individual suffering from a retinal disease, class 1 congestive heart failure, or myocardial infarction using a PDE5 inhibitor► Subscribe
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors► Subscribe
6,143,746 Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use► Subscribe
6,369,059 Tetracyclic derivatives, process of preparation and use► Subscribe
6,841,167 .beta.-carboline pharmaceutical compositions► Subscribe
6,784,179 Tetracyclic derivatives, process of preparation and use► Subscribe
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction► Subscribe
6,127,542 Tetracyclic derivatives, process of preparation and use► Subscribe
6,025,494 Tetracyclic derivatives, process of preparation and use► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tadalafil

Country Document Number Estimated Expiration
Australia702324► Subscribe
World Intellectual Property Organization (WIPO)0108687► Subscribe
Denmark1200092► Subscribe
Austria327756► Subscribe
New Zealand516613► Subscribe
China1213754► Subscribe
Bulgaria62733► Subscribe
Israel147642► Subscribe
Greece1003575► Subscribe
JapanH11509221► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TADALAFIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
081Luxembourg► SubscribePRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0124Netherlands► Subscribe300124, 20150119, EXPIRES: 20171111
2016000039Germany► SubscribePRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
C0017France► SubscribePRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
2003001,C0740668Lithuania► SubscribePRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
017Luxembourg► Subscribe
2016 00024Denmark► SubscribePRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0813Netherlands► SubscribePRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
2003001Lithuania► SubscribePRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
C004/2003Ireland► SubscribeSPC004/2003, 20040610, EXPIRES: 20171111
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Accenture
Healthtrust
McKesson
Deloitte
Medtronic
Cantor Fitzgerald
QuintilesIMS
Moodys
Cerilliant

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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