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Akorn files 28 ophthalmic ANDAs in 2016
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Ophthalmics make up a significant fraction of products for which Akorn has filed abbreviated new drug applications with the FDA.
In a presentation at the 35th annual J.P. Morgan Health Care Conference in San Francisco, Duane A. Portwood, chief financial officer of Akorn, said ophthalmics accounted for 28 of the company’s 92 ANDAs awaiting approval as of the end of 2016. Injectables also comprised a significant share of applications, he said, with 38 having been filed.
The ophthalmic prevalence highlights the company’s emphasis on that market.
“From 2009 to 2012, we focused on our core competencies and on becoming a meaningful player in the niche generic ophthalmics and injectables markets ... and we made a concerted effort to build a solid R&D pipeline in ophthalmic and injectable ANDAs,” Portwood said.
“We believe our key strategic differentiator is our focus on alternate dosage form products,” he continued. “We have a broad and diverse portfolio in ophthalmic, injectable, topical, nasal spray and oral liquid products.”
Portwood added that Akorn markets 38 of the 90 molecules included in QuintilesIMS data. Those 38, he said, carry an IMS market value of $624 million out of the total ophthalmic value of $7.5 billion.
On its website, Akorn lists 52 ophthalmic products among those it offers. In August 2013, Akorn acquired Hi-Tech Pharmacal, a company that specialized in liquid and semi-solid dosage forms, for $640 million. The company then purchased VersaPharm, which developed multisource prescription medications, for $440 million in May 2014. – by Joe Green
- Reference:
- Akorn. 35th Annual J.P. Morgan Healthcare Conference; Jan. 9-12, 2017; San Francisco.