Lupin Limited has received tentative approval from the FDA for its abbreviated new drug application (ANDA) of brimonidine tartrate ophthalmic solution, 0.025% (over the counter [OTC]).
It seems like Lupin has been busy this year …
Indeed. The Mumbai, India-based multinational generic pharmaceutical company also recently announced the successful completion of a global phase 3 clinical study evaluating its biosimilar candidate for Lucentis (ranibizumab; Genentech) 0.5 mg (10 mg/mL) for wet age-related macular degeneration (AMD).
And earlier this year, the company:
- Received FDA approval for the ANDA of loteprednol etabonate ophthalmic suspension 0.2%, a generic equivalent to Alrex, Bausch + Lomb, Inc.’s reference-listed drug
- Launched bromfenac ophthalmic solution, 0.07%, the generic equivalent of Bausch + Lomb’s Prolensa ophthalmic solution, 0.07%
- Received FDA approval for the ANDA of its BromSite (bromfenac ophthalmic solution) 0.075% generic equivalent to treat postoperative inflammation and ocular pain
And the intent behind this most recent move?
Quite simply: Lupin is looking to market its newly-approved brimonidine tartrate solution as a generic equivalent to LUMIFY ophthalmic solution, 0.025% (Bausch + Lomb Corporation).
Now let’s get a rundown on Lumify.
Authorized by the FDA for distribution since 2017, LUMIFY has since been marketed as the first and only OTC eye drop formulated with low-dose brimonidine tartrate to treat ocular redness due to minor eye irritations for adults and children aged 5+.
The recommended dosing: One drop administered into the affected eye(s) every 6 to 8 hours.
- Per its clinical information: LUMIFY’s effects are intended to provide up to 8 hours of relief.
- Important to note: The drops should not be instilled more than four times daily.
- Plus: Contact lenses must be taken out before the drops are administered; patients are advised to wait at least 10 minutes before re-inserting lenses following use.
- Important to note: The drops should not be instilled more than four times daily.
Aren’t there other LUMIFY products now?
Indeed there are! These eye drops were the first product in B+L’s LUMIFY brand which has since expanded to include LUMIFY EYE ILLUMINATIONS, a line of specialty eye care products.
- See our coverage of that September 2023 launch.
And isn’t there a new line of LUMIFY eye drops as well?
Yes! In April 2024, the B+L reported FDA approval of its latest addition: LUMIFY Preservative-Free redness reliever eye drops, intended to treat ocular redness due to minor eye irritations.
- What it does: Significantly reduces ocular redness within 1 minute of application—lasting up to 8 hours, according to John Ferris, B+L’s executive vice president, Consumer.
Gotcha. Now what do we know about this generic?
Per Lupin, the generic version will be manufactured at its facility located in Pithampur, India.
And what does this “tentative approval” mean?
Tentative approval from the FDA is given to a company if its generic drug is ready for approval before the expiration of any patents or exclusivities tied to the generic drug’s reference-listed drug product.
In this case: The patents/exclusivities for LUMIFY are currently preventing Lupin’s generic from being marketed in the United States.
And as a result?
The FDA will delay final approval of Lupin's LUMIFY generic until all patent or exclusivity issues—such as acquiring additional info from the manufacturer or inspecting its manufacturing facilities, although no specifics were provided by the company—are resolved.
Note: This may take several years.