In 2020, the FDA approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis, Kala Pharmaceuticals Inc.) for treating dry eye disease.
As one of the most common ocular surface disorders, dry eye disease impacts 16.7 million to 50.2 million people in the U.S.A. Additionally, this disease costs over $55.4 billion to the economy each year.
Eysuvis ophthalmic suspension 0.25% costs around $534 for 8.3 milliliters (1 unit). Therefore, despite DED’s significant impact on individuals and the economy, only 3 million patients have been able to receive the treatment.
The exclusivity expiration of Loteprednol etabonate will change this scenario, serving as a stimulus to invest in researching and developing Loteprednol Etabonate generic drugs.
Generic drugmakers can seize this opportunity to launch their first loteprednol etabonate generic drug with superior formulations and assert prominence in the evolving market.
In this article, we comprehensively analyze why Loteprednol Etbonate’s generic drug is a market worth capturing.
Current DED Treatment Landscape
The treatment options for European patients are limited; the European Medicines Agency (EMA) has approved only one drug for treating severe keratitis in adults with DED. Additionally, Artificial tears and eye lubricants largely dominate the DED market in the EU, with approximately 96.7% market share in 2018 (Figure 5). Following it are drug products, including cyclosporines, LFA-1 antagonists, mucin secretagogues, and corticosteroids.
Corticosteroids, like dexamethasone or prednisolone, are prescribed more widely in the EU than in the US. However, their market share is approx. 0.5%, which is still relatively small. This low figure reveals various innovative opportunities in Corticosteroids. This is where Loteprednol etabonate comes into the picture.
Loteprednol Etabonate For The Treatment Of Dry Eye Disease
Loteprednol etabonate is a synthetic corticosteroid similar to prednisolone. It is a topical medication, which means that it is applied directly to the skin or eye. It is used to treat inflammations of the eye, such as
- Allergic conjunctivitis
- Giant papillary conjunctivitis
- Uveitis
- Blepharitis
- Dry eye syndrome
It is also used to treat pain and inflammation after cataract surgery.
Companies Holding Loteprednol Etabonate Patents
Bausch and Lomb market Loteprednol under the brand names Lotemax and Loterex. It was patented in 1980 and approved for medical use in 1998. (Source)
Its two primary patents, US4996335 and US5540930, expired in 2013, and since then, we have seen other pharma companies actively working on it.
In 2019, Bausch and Lomb got approval for Lotemax’s new Gel-form variant. Its exclusivity has expired, but its patents still have a long way to go. (Source)
In 2019, the FDA approved the first generic loteprednol eyedrop to Akorn. However, surprisingly, in May 2023, Akorn issued a voluntary recall of various human and animal drug products still within their expiration dates. The recall is due to the company’s recent shutdown, which resulted from poor quality control measures. Eventually, Akron filed for bankruptcy in Feb 2023. (Source)
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Besides Lotemax, Eysuvis and Inveltys are other specialty drugs (no generic version available as claimed on the website) that were branded and marketed by Kala Pharmaceuticals, which have now been acquired by Alcon Labs (Source).
The below-mentioned patents cater to the new innovations in terms of the new strength and new products by global leaders in the space of eye care.
| Drug name | Applicant | Generic name | Patent number | Patent expiry |
|---|---|---|---|---|
| LOTEMAX SM | BAUSCH AND LOMB, INC. | LOTEPREDNOL ETABONATE | US10596107 | 23-12-2036 |
| EYSUVIS | ALCON LABS INC. | LOTEPREDNOL ETABONATE | US11642317 | 03-05-2033 |
| INVELTYS | ALCON LABS INC. | LOTEPREDNOL ETABONATE | US11642317 | 03-05-2033 |
| EYSUVIS | ALCON LABS INC. | LOTEPREDNOL ETABONATE | US11219596 | 03-05-2033 |
| INVELTYS | ALCON LABS INC. | LOTEPREDNOL ETABONATE | US9056057 | 03-05-2033 |
You can explore other patented formulations of Loteprednol Etabonate and their drug expiry date using Pharsight – GreyB’s drug tracking tool.
Conclusion
When looking into this topic, we observed that the searches for the disease have more than doubled since 2013, per Google Trends.
Therefore, it won’t be wrong to say that Loteprednol etabonate is a promising asset, holding solid grounds in treating Dry Eye Disease (DED) and eye inflammation.
While the expiration of exclusivity might suggest an imminent flood of Loteprednol Etabonate Generic Drugs and competitors entering the field, a deeper examination paints a more intricate picture. The patents may endure for a considerable period, extending the runway for incumbent formulations. But to gain a competitive edge, you need to look beyond patents.
Understanding the broader landscape, encompassing disease trends, emerging variants, and treatment trajectories, is essential.
GreyB’s expertise in White Space Analysis will be your powerful ally. Let us do the research while you tap into the massive potential of Loteprednol etabonate in the Dry Eye Disease market. Contact our experts today.
Authored by- Vipin Singh and Mayank Maloo
Edited by: Nidhi, Marketing
