Saptalis launches cyclosporine 0.05% generic amid portfolio expansion

Specialty pharmaceutical company Saptalis Pharmaceuticals LLC is expanding its U.S.-based generic portfolio with the launch of cyclosporine ophthalmic emulsion 0.05%

The debut accompanies the company's FDA approval and commercial launch of five other (non-ophthalmic) products.

Hold up—didn’t we just hear about this generic’s launch?

Not from Saptalis. However, your déjà vu is warranted: Upsher-Smith actually launched its own generic cyclosporine 0.05% late last month.

See here for our coverage.

Gotcha. Well, before we revisit the topic … let’s get a rundown on Saptalis.

Founded in 2015 and headquartered in Hauppauge, New York, Saptalis specializes in the research, development, manufacturing, and commercialization of two product types in two distinct forms:

The types: generics and specialty branded
- Includes over-the-counter (OTC) and prescription-based (Rx)
The forms: liquids and semi-solid dosages

As for its targeted therapeutic areas—these include ophthalmology, dermatology, psychiatry, and allergy-related.

See here for a look at its products and current pipeline. And check out its partnerships with global collaborators for co-development and licensing deals.

Now to our topic of discussion: its newest generic.

Saptalis’s cyclosporine ophthalmic emulsion 0.05% was granted FDA abbreviated new drug application (ANDA) approval in July 2024.

See its approved status listed in the FDA database.
And the company’s approval announcement can be found here.

Next up: indication and dosing details.

The drop’s indication: To increase tear production in patients whose tear production is presumed suppressed due to ocular inflammation associated with keratoconjunctivitis.

To be more precise: This concentration of cyclosporine (0.05%) targets inflammation as an underlying cause of dry eye.

As for dosing: One drop of the emulsion should be instilled twice a day (BID) in each eye, approximately 12 hours apart (and 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.

Check out its complete prescribing information (PI) for more details.

And its branded product counterpart?

That would be Restasis (cyclosporine ophthalmic emulsion) 0.05%, a registered trademark of Allergan Inc., an AbbVie company and indicated for topical ophthalmic administration.

Notably: Its PI and Saptalis’s generic PI mirror each other.

How about for contact lens wearers?

Generally speaking, patients with decreased tear production shouldn’t be wearing lenses.

But if they do: They’re advised to remove the lenses before instillation and wait 15 minutes before reinsertion.

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?

To be determined. But according to Saptalis product listing, the generic will be available in 30- and 60-day single-dose vials.

Reach out to the company for more details!

What else should we know?

This isn’t the first cyclosporine 0.05% generic to receive FDA ANDA approval. Aside from Upsher-Smith’s generic last month, we’ve also covered a few others from