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Generic brimonidine ophthalmic solution launches for IOP reduction

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4 min read

Alembic Pharmaceuticals Limited has launched brimonidine tartrate ophthalmic solution, 0.1%, the generic equivalent of ALPHAGAN P ophthalmic solution by AbbVie for the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).

I’m not too familiar with Alembic…

Founded in 1907 and headquartered in Vadodara, India—with a U.S. subsidiary in Bedminster, New Jersey (operating as Alembic Pharmaceuticals, Inc.)—the multinational pharmaceutical company supplies products to 90+ countries across the globe.

Its expertise includes research and development (R&D), manufacturing and marketing of finished dosage formulations, active pharmaceutical ingredients (APIs), and intermediates.

In the U.S., the company has sold 100+ products since 2015 and currently has 100+ projects in progress within the following targeted therapeutic and drug delivery areas: dermatology, injectables, and ophthalmology.

And its generic products?

After launching 20 new products within the first 9 months of 2023 and 11 new products in Q3 2023 alone, reports noted the company’s sales increased from $53 million in Q2 2023 to $57 million by Q3 2023.

For 2024, Alembic anticipates launching 5 to 6 new products to the U.S. market—each quarter.

Check out its current product list here.

Now talk about this product.

Alembic’s two brimonidine tartrate ophthalmic solution formulations, 0.15% and now 0.1%, are both considered an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with OAG or OHT.

Recommended dosage?

Per the prescribing information (PI) for each formulation, one drop should be administered into the affected eye(s) three times daily (TID), approximately 8 hours apart.

Note: one bottle of solution contains 1.5 mg/mL of brimonidine tartrate in a 5 mL bottle.

Can it be used with other medications?

Yes! The PI notes other topical ophthalmic formulations can be used concomitantly to lower IOP.

However, if more than one other topical glaucoma therapies is used, they should be instilled at least 5 minutes apart.

Any warnings and precautions to be aware of?

Just a few…

  • Increased chance for vascular insufficiency
    • Solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s Phenomenon, orthostatic hypotension, or thromboangiitis obliterans (Buerger disease).
  • Severe cardiovascular disease
  • Contamination of topical ophthalmic product after use
    • Reports of bacterial keratitis associated with multiple-dose containers of topical ophthalmic products by patients with concurrent corneal disease or ocular epithelial surface disruption

Potential adverse reactions, based on clinical trials, can be found here.

How does this compare to Alphagan P?

Originally FDA-approved in 1996 as ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.2%, the concentration was reduced upon FDA approval in 2006 for ALPHAGAN P (0.1% and 0.15%) to potentially mitigate certain adverse reactions (specifically, conjunctival hyperemia).

With this said, the ALPHAGAN P formulations share the same indication, dosage recommendations, warnings/precautions, and potential adverse reactions based on clinical trial data.

See their respective PIs here (0.1%) and here (0.15%).

And how much might this generic cost?

GoodRx reports that a generic version of ALPHAGAN P (0.1%) may run anywhere from $32 (low) to $153 (high).

Compare that price to the name brand, as seen here.