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Nirmal Bang Report
Ophthalmic and OTIC suspensions represent a niche complex category in the overall U.S. pharmaceutical market.
We estimate the cumulative market opportunity, represented by products in this category, at $800 million-$1,000 million.
Generic players find it challenging to develop copies of them owing to the complexity in manufacturing process and complex bioequivalence requirements (physiochemical bioequivalence).
The challenges of development get magnified as products in this category are quite small in size which makes it less attractive for the large generic players to invest resources in.
So far, Indoco Remedies Ltd. and Sun Pharmaceutical Industries Ltd. are the only Indian generic manufacturers to have successfully won approvals for generic version of Ophthalmic suspensions in the U.S. market.
Indoco Remedies has recently launched generic version of Azopt (brinozolamide) while Sun Pharma also only recently received approval for gLotemax (loteprednol suspension).
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