Glenmark Pharmaceuticals Inc. has received final approval from the FDA for olopatadine hydrochloride ophthalmic solution USP, 0.2% (over-the-counter [OTC]) to be a bioequivalent to Alcon’s Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC).
To be more specific: The product was granted abbreviated new drug application (ANDA) approval—but more on that in a moment.
Let’s start with Glenmark.
What it is: A multinational, research-led pharmaceutical company developing branded, generic, and OTC products in five therapeutic areas.
Its operations: Glenmark is headquartered in Mumbai, India, with a U.S. arm (under the name Glenmark Therapeutics Inc., USA.) in Mahwah, New Jersey.
Now explain this ANDA.
An “abbreviated” NDA refers to generic drug compounds that are comparable to an already FDA-approved drug product.
- The distinct difference from an NDA: Unlike an NDA, preclinical and clinical data isn’t required in order to establish the safety and efficacy of a drug compound.
As for the approval process: A generic drug must be tested on a small group of patients to evaluate whether it is “bioequivalent.”
- In other words: A generic drug must be able to reach the target tissue where it is intended to work at the same time and in the same amount (concentration level) as the brand-name medication.
So how does this need to be demonstrated?
To be granted approval, the generic drug needs to deliver “the same amount of active ingredients in a patient’s bloodstream in the same amount of time” as the already-approved drug.
And the intended outcome?
The ANDA process essentially enables the FDA to approve applications to market generic versions of brand-name drugs without the need for costly clinical trials.
A key benefit of generics for patients: This generic drug is a potentially lower-cost alternative to the commercially available brand-name medication.
- And notably: Despite generics now comprising over 90% of prescriptions in the U.S., it remains a heavy source of skepticism—with patients and clinicians alike questioning whether they skimp on quality.
Alrighty. Now talk about this bioequivalent.
The best way to learn about this ophthalmic solution is by getting familiar with Alcon’s Pataday Once Daily Relief—notably: the “first eye allergy itch relief drop available without a prescription with once daily dosing.”
Its purpose: The olopatadine ophthalmic solution is intended to be used as an antihistamine to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander.
I take it the dosing schedule is … once a day?
You guessed right.
The dosings:
- For adult and pediatric patients (aged 2+): One drop should be instilled in the affected eye(s) once daily—and no more than once per day.
- If using other ophthalmic products while using Pataday, it is advised to wait 5 minutes in between products.
- For pediatric patients (under aged 2): Parents are advised to consult their optometrist.
And how long is relief expected to last?
Ideally: Up to 16 hours.
Any warnings associated with its use?
Patients are asked not to use the eye drop in the following circumstances:
- The solution changes color or appears cloudy
- They (the patient) are sensitive to any ingredients included in the formulation (see here for inactive ingredients)
- To treat contact lens-related irritation
Along those lines, what adverse symptoms should patients look out for?
Patients are asked to stop drop use and notify their optometrist if they experience:
- Ocular pain
- Vision changes
- Increased redness in the eye
- Ocular itching lasting more than 72 hours
Got it. So what do we know about this generic version?
Not too many details were released, aside from the fact that the ophthalmic solution will be distributed in the United States by Glenmark’s U.S. division.
To note: This is actually the second olopatadine hydrochloride solution to receive an ANDA from the FDA; Glenmark was already approved for (and currently markets) the generic version of Pataday Twice Daily Relief (olopatadine hydrochloride ophthalmic solution USP, 0.1% OTC).
And when will the olopatadine hydrochloride 0.2% solution be available?
No word yet. Check back here in the near future for details on purchasing options.