Just over 2 months after receiving FDA abbreviated new drug application (ANDA) approval, Glenmark Pharmaceuticals Inc. announced the U.S. launch of olopatadine hydrochloride (HCl) ophthalmic solution USP, 0.2%.
Isn’t Glenmark an Indian-based pharmaceutical company?
Indeed it is. However, the multinational, research-led organization has a U.S. arm based in Mahwah, New Jersey: Glenmark Therapeutics Inc., USA.
As for Glenmark’s portfolio: It comprises branded, generic, and over-the-counter (OTC) products for five key therapeutic areas.
So which category does this solution fall under?
That would be OTC and generic.
Specifically: The olopatadine HCl ophthalmic solution is a generic version of Pataday Once Daily Relief (Alcon, Inc.)—marketed as the “first eye allergy itch relief drop available without a prescription with once daily dosing.”
- Its indication: To be used as an antihistamine to temporarily relieve itchy eyes due to pollen, ragweed, animal hair, and dander.
Real quick: Talk about olopatadine.
Generally speaking, prescription and non-prescription ophthalmic olopatadine is used to treat ocular itching caused by allergic conjunctivitis (pink eye).
How it works: By preventing the effects of specific inflammatory substances (histamines) that are produced by cells in the eye and can sometimes cause an allergic reaction.
What dosing schedule does it follow?
As Pataday’s name implies, this solution is intended to be used no more than once a day. Its drug information recommends:
- 1 drop should be administered into the affected eye(s) once daily
- If using other ophthalmic products while using this solution, wait 5 minutes (at a minimum) between each product
How long does it take for ocular relief to kick in?
Within minutes.
To note: This is based on Pataday’s product benefits page (and keep in mind: Glenmark’s eye drop is formulated to be bioequivalent to that solution).
And what age groups are permitted to use these drops?
Ideally, patients aged 2+. For pediatric patients under the age of 2, parents should consult their optometrist.
Gotcha. So, any warnings or precautions to be aware of?
Patients are advised to immediately stop drop use if:
- The solution changes color or appears cloudy
- They develop sensitivity to any ingredients (including inactive) in the drop’s formulation
- They are trying to treat contact lens-related irritation
And what ocular symptoms should be a cause for concern?
If any of the following develop after drop use, patients should reach out to their eyecare provider:
- Eye pain
- Vision changes
- Increased eye redness
- Worsening itching that last >72 hours
Duly noted. Now, where are these drops available?
Per Glenmark’s product page for the new solution, they will be available for purchase through:
Available sizes include a 2.5 mL bottle or 2.5 mL x 2 bottles (in a twin pack)
Note: Pricing will vary.
What else to know?
This is actually the second concentration of the olopatadine HCl ophthalmic solution that Glenmark has received ANDA approval for.
- The company is already marketing a generic version of Alcon’s Pataday Twice Daily Relief (olopatadine hydrochloride ophthalmic solution USP, 0.1% OTC).