Lupin Ltd. announced the U.S. launch of bromfenac ophthalmic solution, 0.07%, the generic equivalent to Prolensa ophthalmic solution, 0.07% (Bausch + Lomb).
Quick refresh on this company.
Headquartered in Mumbai, India, with a U.S. subsidiary in Baltimore, Maryland, Lupin is a multinational generic pharmaceutical company developing and commercializing a portfolio of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs).
Its areas of focus include:
- Pediatrics
- Cardiovascular
- Anti-infective
- Diabetes
- Asthma
- Anti-tuberculosis
Let’s zero in on its generics …
Since entering the U.S. generic pharmaceuticals market in 2003, the company reports having received 250+ FDA approvals, with 180 generic products currently marketed.
Click here for the company’s generic product list.
And this new product?
Categorized as a nonsteroidal anti-inflammatory drug (NSAID), bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery.
Per the FDA’s standards for generic equivalents (see here for details on that process), the solution’s mechanism of action (MOA) and indication are intended to match that of Prolensa, an NSAID originally approved by the FDA for the same indication in 1997.
To note, the solution is available in 3 mL bottle size.
Talk about dosings.
According to the generic’s prescribing information (PI), the recommended dosing is one drop of the solution applied to the affected eye once daily, beginning one day before cataract surgery, then on the day of surgery and continuing through the first 14 days of post-op.
See here for a comparison between the Lupin generic equivalent and the brand name Prolensa PI.
Can it be used with other topical ophthalmic medications?
Per the PI, yes, the solution can be administered along with other topical medications, such as:
- Alpha-adrenergic agonists
- Beta-blockers
- Carbonic anhydrase inhibitors (CAIs)
- Cycloplegics
- Mydriatics
However, the drops must be administered at least 5 minutes apart.
Any warnings/precautions to be aware of?
A few… including potential slow/delayed healing, increased bleeding time, sulfite allergic reactions, keratitis, and other corneal reactions. See here for the complete list.
Of note, for keratitis and corneal reactions, the PI states that use of the bromfenac solution more than 24 hours prior to surgery or use beyond 14 days postop may “increase patient risk for the occurrence and severity of corneal adverse events.”
What else should I know?
Lupin reported that it is the exclusive first-to-file for this generic product, and is also eligible for 180-day exclusivity.
Translation: This means the company has up to 180 days of marketing exclusivity in the U.S. from the FDA—preventing any other company from launching its own product during this period.
This essentially gives Lupin the opportunity to price its product below the branded version (for up to 180 days or 6 months), potentially taking market share from the branded product and maintaining its price point before any other generics enter the market.
So how much is this generic going to cost for a patient?
No specific word from Lupin. However, here’s a look from GoodRx, Inc. at Prolensa’s patient cost at the moment.