Dr. Reddy’s Laboratories Ltd. announced the U.S. commercial launch for olopatadine hydrochloride (HCl) ophthalmic solution USP, 0.7%—a generic equivalent to Alcon, Inc.’s Pataday Once Daily Extra Strength eye drops.
Importantly: The company referred to this as the “first-to-market” launch for the generic.
Explain what that means.
Exactly what it sounds like, really.
A “first-to-market” launch for a generic refers to its manufacturer (in this case: Dr. Reddy’s) becoming the first generic drug manufacturer to receive FDA approval (via an abbreviated new drug application [ANDA]) and enter the commercial market for a specific name-brand drug (in this case: Alcon’s Extra Strength Pataday).
Click here for a rundown on first-to-market generic launches and see here for a closer look at the FDA’s list of other first generic drug approvals/
Noted. Now in regards to this generic—didn’t the FDA just grant its approval?
We definitely did just have a U.S. regulatory approval for generic Extra Strength Pataday OTC eye drop (last week; read up on it here).
- However, that was for Glenmark Pharmaceutical's product, not Dr. Reddy’s.
In other words: Two different companies, each with its own generic version of the eye drop (though Glenmark’s product has not yet launched to the U.S. commercial market).
Ah … gotcha. Well then, let’s talk about this generic.
We quite literally gave a rundown on everything to know regarding olopatadine last week.
- So see here for those details.
And also take note: Olopatadine has had a few generic approvals (and launches) within the last couple of years—both for its 0.2% and 0.7% concentrations.
And what should we know about the name-brand version of the formulation?
Alcon’s Extra Strength Pataday was originally granted FDA approval in 2020 as an over-the-counter (OTC) eye drop alternative to the prescription-based Pazeo.
Its indication: For topical administration as an antihistamine to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander.
Next up: Dosing and symptom relief.
Its recommended dosing: 1 drop administered into the affected eye(s) once daily (and no more) for adult and pediatric patients (aged 2+).
- See here for a few other notes.
As for how soon its effects are 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
Go on …
A few other words of caution for users:
- If using other ophthalmic products while also using these drops, their respective administrations should be spaced at least 5 minutes apart.
- And if wearing contact lenses, wearers should remove their lenses prior to administering the drops and only reinsert the lenses after waiting 10 minutes post-administration.
- Notably, If a patient’s eye(s) are red, they should not be wearing their lenses.
So, when shouldn’t these drops 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
Lastly, where can patients find this OTC generic for themselves?
Dr. Reddy’s generic eye drop will be available in a 2.5 mL bottle … but no word yet on where it can be purchased.
Check back at the manufacturer’s website for details.