Elite Pharmaceuticals Inc (ELTP)

[Trend-Setter]

Right Timing!
Oxycodone Hydrochloride extended release (generic version of OxyContin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing, compliance with which would require significant resources. Development of this product has been reinitiated with a target filing in Q1 2023 --- Latest 10-K filing