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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

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, 2003RXYes6,943,166<disabled> <disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYes7,182,958<disabled>Y <disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXNo6,140,329<disabled>Y <disabled>
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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;ORAL021368-001Nov 21, 20036,140,329<disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 20036,140,329<disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 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
6,451,807 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<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
Hong Kong1044278<disabled in preview>
Canada2340636<disabled in preview>
Germany10399006<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
C004/2003Ireland<disabled>SPC004/2003, 20040610, EXPIRES: 20171111
2003001Lithuania<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
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