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Lupin Launches First Generic of Pred Forte® in the United States

October 15, 2024

Prednisolone Acetate Ophthalmic Suspension is the first generic version of Pred Forte® Lupin has commenced shipment with a 180-day CGT exclusivity

Mumbai, Naples, October 15, 2024: Global pharma major Lupin Limited (Lupin) today announced the launch of the first generic version of Pred Forte® (Prednisolone Acetate) Ophthalmic Suspension USP, 1% in the United States. Being the first generic to be approved and launched, the company is entitled to 180-day competitive generic therapy (CGT) exclusivity.

Prednisolone Acetate Ophthalmic Suspension USP, 1% is a generic equivalent of Pred Forte® Ophthalmic Suspension, 1% of AbbVie, Inc. and is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Pred Forte® had estimated annual sales of USD 198 million in the U.S. (IQVIA MAT August 2024).

“The launch of Prednisolone Acetate Ophthalmic Suspension is a milestone and is aligned with our commitment to enhancing access to innovative, affordable and quality healthcare solutions,” said Vinita Gupta, CEO, Lupin. “This will strengthen our ophthalmic portfolio and will benefit patients seeking effective treatment for steroid-responsive inflammation.”

About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –

Rajalakshmi Azariah

Vice President & Global Head – Corporate Communications, Lupin

rajalakshmiazariah@lupin.com

*Safe Harbor Statement

Pred Forte® is a registered trademark of Allergan, Inc., an AbbVie company.

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