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CIALIS Drug Profile

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

This drug has three hundred and five patent family members in sixty-two countries.

The generic ingredient in CIALIS is tadalafil. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. There are three tentative approvals 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
Drug Prices: :see details

Pharmacology for Tradename: CIALIS

Clinical Trials for: CIALIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYes6,943,166Apr 26, 2020
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYes7,182,958Apr 26, 2020Y
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXNo6,140,329Jul 11, 2016Y
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Expired Patents for Tradename: CIALIS

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 20036,140,329<disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 20036,140,329<disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 20036,140,329<disabled>
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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
6,841,167 .beta.-carboline pharmaceutical compositions<disabled in preview>
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors<disabled in preview>
6,369,059 Tetracyclic derivatives, process of preparation and use<disabled in preview>
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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
Czech Republic20020386<disabled in preview>
Austria327756<disabled in preview>
Portugal102457<disabled in preview>
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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
2003001,C0740668Lithuania<disabled>PRODUCT 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
2016 00024Denmark<disabled>PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0813Netherlands<disabled>PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
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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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