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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKesson
Fuji
Cerilliant
US Department of Justice
McKinsey
Daiichi Sankyo
Express Scripts
Cipla
Farmers Insurance

Generated: November 22, 2017

DrugPatentWatch Database Preview

CIALIS Drug Profile

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What is the patent landscape for Cialis, and when can generic versions of Cialis launch?

Cialis is a drug marketed by Lilly and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in CIALIS is tadalafil. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
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► Subscribe ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo► 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► Subscribe ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo► Subscribe► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: CIALIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 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
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for CIALIS

Drugname Dosage Strength RLD Submissiondate
tadalafilTablets2.5 mgCialis10/14/2008
tadalafilTablets5 mg, 10 mg and 20 mgCialis11/21/2007

Non-Orange Book Patents for Tradename: CIALIS

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
6,841,167 .beta.-carboline pharmaceutical compositions► 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
6,784,179 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
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
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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 Tradename: CIALIS

Country Document Number Estimated Expiration
Norway980154► Subscribe
TunisiaSN95004► Subscribe
China1196487► Subscribe
El Salvador2002000055► Subscribe
Brazil0012901► Subscribe
Brazil9506559► Subscribe
Greece20000100153► Subscribe
Singapore98384► Subscribe
Slovakia284494► Subscribe
Germany60010089► 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: CIALIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0813Netherlands► SubscribePRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
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
0740668/01Switzerland► SubscribePRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
017Luxembourg► Subscribe
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
2016000039Germany► SubscribePRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0124Netherlands► Subscribe300124, 20150119, EXPIRES: 20171111
C004/2003Ireland► SubscribeSPC004/2003, 20040610, EXPIRES: 20171111
2003 00008Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Army
Citi
Harvard Business School
Healthtrust
Covington
Fish and Richardson
Merck
Queensland Health
Federal Trade Commission

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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