Gland Pharma Limited has reportedly received FDA approval for olopatadine hydrochloride (HCl) ophthalmic solution USP, 0.7%—a generic equivalent to Alcon, Inc.’s Pataday Once Daily Extra Strength eye drops.
First, a look at Gland Pharma.
Headquartered in India, this small-molecule generic injectables manufacturing company has expanded its global footprint to 60+ countries since its establishment in 1978.
Its portfolio of injectable products extends across multiple therapeutic segments and delivery systems—including ophthalmology.
Now let’s talk generics.
Generally speaking, a generic’s FDA approval is granted based on its formulation containing the exact same active ingredient as a brand-name counterpart, as well as the same strength, quality, and effectiveness.
Is there a difference between generic versus brand name?
It all comes down to the pricing of the drugs, where the generic’s purpose is to serve as a lower-cost alternative with the same therapeutic effect as its name-brand counterpart.
- Check out the generic approval process, which requires an abbreviated new drug application (ANDA) approval from the FDA.
Noted. So about this olopatadine HCl solution generic …
First, a quick rundown on olopatadine can be found here.
As we mentioned, the generic formulation is intended to be the equivalent to the name-brand, over-the-counter (OTC) Extra Strength Pataday Once Daily Relief (not to be confused with Pataday Once Daily Relief, which has a lower concentration of olopatadine).
Wait, didn’t we just hear about a Pataday generic approval?
Yes—in April 2025 (our coverage here), which was followed by a U.S. commercial launch just 2 months later, in June 2025.
However, that approval was for a generic of the aforementioned Pataday Once Daily Relief (olopatadine HCl ophthalmic solution USP, 0.2%), manufactured by Glenmark Pharmaceuticals, Inc.
Ahh gotcha. So what do we know about this Extra Strength Pataday?
This extra strength formulation was granted FDA approval in 2020 as an OTC eye drop alternative to the prescription-based Pazeo.
Its purpose: To be used as an antihistamine to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander.
And the dosing requirements?
Based on Pataday’s product labeling, the ophthalmic formulation is intended to be topically administered no more than once a day in each eye.
The recommendation for adult and pediatric patients (aged 2+): 1 drop should be administered into the affected eye(s) once daily.A couple of notes:
- If using other ophthalmic products while using this solution, wait 5 minutes (at a minimum) between each product
- A physician should be consulted prior to use on a patient under the age of 2.
How soon is symptom relief felt?
Reportedly, within minutes, with relief lasting 24 hours.
Any warnings or precautions to be aware of?
Patients are advised to stop drop use and seek a physician if they begin experiencing:
- Eye pain
- Vision changes
- Increased redness of the eye
- Worsening eye itching or itching lasting more than 72 hours
Additionally: If using other ophthalmic products while also using these drops, their respective administrations should be spaced at least 5 minutes apart.
And if patients wear contact lenses?
Wearers should remove their lenses prior to administering the drops and only reinsert the lenses after waiting 10 minutes post-administration.
If a patient’s eye(s) are red, they should not be wearing their lenses.
Are there any circumstances in which these drops shouldn’t be used?
Patients should not use the drops under the following instances:
- If the solution changes color or appears cloudy
- If a patient is sensitive to any of the ingredients in the formulation (including olopatadine and all inactive ingredients).
- To treat contact lens-related irritation
Noted. So … when (and where) will this generic version be commercially available?
No word yet on that quite yet … check back with Gland Pharma (and stay tuned for a Glance update) in the near future!