Teva Announces Exclusive First-to-File Launch of a Generic Version of Cialis in the United States
JERUSALEM--- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the exclusive first-to-file launch of a generic version of Cialis?1 (tadalafil) tablets (2.5 mg, 5 mg, 10 mg, 20 mg) in the U.S.
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH (ED/BPH).
Teva?s EVP and Head of Global R&D, Hafrun Fridriksdottir said, ?We?re proud to offer an affordable treatment option for the estimated 30 million men affected by ED, many of whom will also have symptomatic BPH which is estimated to affect 15 million men in the United States.?
Brendan O?Grady, EVP and Head of North America Commercial at Teva added, ?This launch represents an important addition to our generics portfolio, building on our exclusive launch of a generic version of Viagra? (sildenafil) tablets?last year. We?re committed to ensuring that patients are able to access this medicine.?
With over 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Cialis? had annual sales of nearly $1.93 billion in the U.S., according to IQVIA data as of July 2018.
About Tadalafil Tablets
Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and ED and the signs and symptoms of BPH (ED/BPH). If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.
IMPORTANT SAFETY INFORMATION
Nitrates: Tadalafil tablets are contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates.
Hypersensitivity Reactions: Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (or ADCIRCA?). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.
Concomitant Guanylate Cyclase (GC) Stimulators: Do not use tadalafil in patients who are using a GC stimulator, such as riociguat. Phosphodiesterase 5 (PDE5) inhibitors, including tadalafil, may potentiate the hypotensive effects of GC stimulators.
Cardiovascular: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including tadalafil, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.
PDE5 inhibitors, including tadalafil tablets, are mild systemic vasodilators. While this effect should not be of consequence in most patients, physicians should consider this potential when prescribing tadalafil tablets.
Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Patients with certain types of cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil, and therefore tadalafil is not recommended for the following groups of patients:
- Myocardial infarction within the last 90 days
- Unstable angina or angina occurring during sexual intercourse
- New York Heart Association Class 2 or greater heart failure in the last 6 months
- Uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension
- Stroke within the last 6 months
- The uncertainty of the commercial success of our generic version of tadalafil, including due to a potential launch of an Authorized Generic version;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE?, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
- our business and operations in general, including: failure to effectively execute the restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex?Medicare?and?Medicaid reporting and payment obligations; and environmental risks;
- other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;
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Source: Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd. IR Contacts United States Kevin C. Mannix, 215-591-8912 or Israel Ran Meir, 215-591-3033 or PR Contacts United States Elizabeth DeLuca, 267-468-4329 or Israel Yonatan Beker, 972 (54) 888 5898