Sandoz launches authorized generic version of Pataday® 0.2% ophthalmic solution
Jun 12, 2017
Princeton, New Jersey, June 12, 2017– Sandoz today announced the US market introduction of Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, an authorized generic version of Pataday® by Alcon1. Sandoz’s Olopatadine Hydrochloride Ophthalmic Solution, 0.2%2 is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
"As a division of Novartis, we are pleased to have the opportunity to further drive access to this critical medicine in the US market,” said Peter Goldschmidt, President of Sandoz Inc. “By working internally with the Novartis group, Sandoz is able to deliver a wide range of ophthalmic dosage forms that require high technical expertise.”
According to IMS Health, US sales for Pataday were approximately USD 293 million for the 12 months ending in April 2017.
Olopatadine Hydrochloride Ophthalmic Solution, 0.2% is for topical ocular use only, not for injection or oral use.
As with any eye drop, to prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.
Patients should be advised not to wear a contact lens if their eye is red. Olopatadine Hydrochloride Ophthalmic Solution, 0.2% should not be used to treat contact lens-related irritation.
The preservative in Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling Olopatadine Hydrochloride Ophthalmic Solution, 0.2% before they insert their contact lenses.
Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. The following adverse experiences have been reported in 5% or less of patients:
Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.
Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.
Some of these events were similar to the underlying disease being studied.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “opportunity,” or similar terms, or by express or implied discussions regarding potential future product approvals, or regarding potential revenues from olopatadine hydrochloride ophthalmic solution, 0.2%. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any potential new products will receive regulatory approval in the future, or that olopatadine hydrochloride ophthalmic solution, 0.2% or any such potential new products will be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional generic versions of olopatadine hydrochloride ophthalmic solution, 0.2% for sale; government, industry and general public pricing and reimbursement pressures; litigation outcomes; safety, quality or manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.