Upsher-Smith Laboratories, LLC, a subsidiary of Bora Pharmaceuticals Co., Ltd., has launched a generic version of cyclosporine ophthalmic emulsion 0.05% to the U.S. commercial market.
Let’s begin with Upsher-Smith.
Based in Maple Grove, Minnesota, the U.S. pharmaceutical company operates as a generic manufacturer and marketer.
- Some background: Its 2024 acquisition by Bora folded the company into the largest Taiwanese global manufacturer.
As for its portfolio: Upsher-Smith offers an extensive category of generics and product patents—see here and here, respectively.
Speaking of generics …
Upsher-Smith’s generic version of cyclosporine ophthalmic emulsion 0.05% was granted FDA abbreviated new drug application (ANDA) approval earlier this year (January 2026).
Details on this approval pathway can be found here.
Its indication: To increase tear production in patients whose tear production is suppressed due to ocular inflammation associated with keratoconjunctivitis.
And more specifically?
This concentration of cyclosporine (0.05%) targets inflammation as an underlying cause of dry eye.
Noted. So what’s the name-brand version of this generic?
Granted FDA approval in 2003, Restasis (cyclosporine ophthalmic emulsion) 0.05% is a registered trademark of Allergan Inc., an AbbVie company.
Per its prescribing information: The emulsion, similar to its generic counterpart, is indicated for topical ophthalmic use.
Talk dosing.
According to the generic drop’s PI (which mirrors the PI for Restasis, keep in mind):
- One drop of the emulsion should be instilled twice a day (BID) in each eye, approximately 12 hours apart.
- Each single-use vial should be immediately discarded after use.
To note: The emulsion can be used concomitantly with lubricant eye drops—as long as a 15-minute interval between products is followed.
How about for contact lens wearers?
While the PI noted that patients with decreased tear production shouldn’t generally be wearing lenses—for those who do: the 15-minute rule also applies once the lenses have been removed pre-instillation.
Any warnings or precautions to consider?
Check out the following:
- Contraindications
- Warnings and precautions (lens wear is also included in this)
- Potential adverse reactions (including post-marketing reports)
So … where will this be available for purchase?
No word yet. Check back here for the product’s availability via Upsher-Smith’s online catalogue.
Two packaging options will be available:
- 0.4 mL vials (30-count)
- 0.4 mL vials (60-count)
Reach out directly to the company for more details on pricing.
And in the meantime, aren’t there other generic versions of this drop?
Indeed there are—in fact, as we’ve covered: Amneal Pharmaceuticals received FDA ANDA approval late last year and Mylan Pharmaceuticals version was approved in 2022.
And more recently: Rain Eyecare just announced its new telehealth platform will offer the generic eye drop for qualifying patients.
See here for a look at other approvals.