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Serving 500+ biopharmaceutical companies globally:

Cipla
Express Scripts
Johnson and Johnson
Federal Trade Commission
Covington
Dow
Daiichi Sankyo
AstraZeneca
US Army
Queensland Health

Generated: July 20, 2017

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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 ten patent family members in sixty-two 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.

Summary for Tradename: CIALIS

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list9
Bulk Api Vendors: see list60
Clinical Trials: see list28
Patent Applications: see list3,376
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:CIALIS at DailyMed

Pharmacology for Tradename: CIALIS

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, 2003RXYesYes6,821,975► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXYesNo5,859,006► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo5,859,006► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo6,140,329► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003RXYesNo5,859,006► 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;ORAL021368-004Jan 7, 20086,140,329► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 20036,140,329► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 20036,140,329► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 20036,140,329► Subscribe
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Paragraph IV activity 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
6,369,059 Tetracyclic derivatives, process of preparation and use► Subscribe
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction► Subscribe
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors► Subscribe
6,784,179 Tetracyclic derivatives, process of preparation and use► Subscribe
6,127,542 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 Tradename: CIALIS

Country Document Number Estimated Expiration
Canada2181377► Subscribe
ItalyMI20000922► Subscribe
World Intellectual Property Organization (WIPO)0108688► Subscribe
European Patent Office1113800► Subscribe
Portugal1200090► 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
0124Netherlands► Subscribe300124, 20150119, EXPIRES: 20171111
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
2003 00008Denmark► Subscribe
C004/2003Ireland► SubscribeSPC004/2003, 20040610, EXPIRES: 20171111
C/GB03/007United Kingdom► SubscribePRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
AstraZeneca
Queensland Health
Express Scripts
Deloitte
Mallinckrodt
Johnson and Johnson
Fish and Richardson
Covington
Baxter

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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