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Profile for Tradename: CIALIS

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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 four patent family members in sixty-two countries.

The generic ingredient in CIALIS is tadalafil. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. There are two 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 list39
2013 Sales:$1,086,355,000

Pharmacology for Tradename: CIALIS

Clinical Trials for: CIALIS

Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying
Status: Completed Condition: Gastroparesis

A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis
Status: Active, not recruiting Condition: Pulmonary Arterial Hypertension; Systemic Sclerosis; Scleroderma Spectrum of Diseases; Connective Tissue Disease; Pulmonary Hypertension

PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC
Status: Not yet recruiting Condition: Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer

Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Status: Completed Condition: Benign Prostatic Hyperplasia

PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension
Status: Completed Condition: Pulmonary Hypertension

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs
Status: Completed Condition: Hypertension, Pulmonary

Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Status: Completed Condition: Benign Prostatic Hyperplasia

A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
Status: Completed Condition: Erectile Dysfunction

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma
Status: Terminated Condition: Multiple Myeloma

Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
Status: Completed Condition: Impotence

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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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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
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors<disabled in preview>
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>
6,784,179 Tetracyclic derivatives, process of preparation and use<disabled in preview>
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International Patent Family for Tradename: CIALIS

Country Document Number Publication Date
Slovakia284141Oct 05, 2004
United Kingdom9401090Mar 16, 1994
Hungary0200912Aug 28, 2002
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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