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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 eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the tadalafil profile page.

Summary for Tradename: CIALIS

Patents:5
Applicants:1
NDAs:1
Suppliers: see list9
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

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

A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
Status: Completed Condition: Erectile Dysfunction

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, 2003RXYes6,821,975<disabled>YY<disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXNo5,859,006<disabled>YY<disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXNo<disabled><disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXNo6,140,329<disabled>Y<disabled>
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 2008RXNo<disabled><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

International Patent Family for Tradename: CIALIS

Country Document Number Publication Date
European Patent Office0839040May 06, 1998
European Patent Office1415652May 12, 2004
Spain2220506Dec 16, 2004
Poland353268Nov 03, 2003
World Intellectual Property Organization (WIPO)9703985Feb 06, 1997
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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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