The anti-seizure drug is a generic of Dilantin 100 mg capsules, developed by Pfizer Inc’s division Parke-Davis.
Extended phenytoin sodium capsules 100 mg had annual sales of approximately $105 million in the US in the year ending June, according to Lupin’s release quoting data from market research firm IQVIA.
The capsules are indicated for prevention and treatment of seizures occurring during or following neurosurgery and for treatment of tonic-clonic and psychomotor seizures.
In November last year, Lupin had announced that the US FDA had given an establishment inspection report (EIR) for its Nagpur facility following the successful completion of a pre-approval inspection for the drug. The inspection, conducted in September 2018, concluded without any observations.
Lupin's Nagpur facility manufactures oral solid dosage products, and also houses its injectable manufacturing facility.
The drug maker is a significant player in the cardiovascular, diabetology, asthma, pediatric, central nervous system, gastrointestinal, anti-infective and non-steroidal anti-inflammatory drugs and holds global leadership position in the Anti-tuberculosis segment.
Lupin is the eighth largest generics pharmaceutical company by revenues for the previous financial year, and the 3rd largest pharmaceutical player in the US by prescriptions, as per the company’s release.
For the financial year ended March, Lupin’s Consolidated net sales and net profits were at Rs. 163.7 billion and Rs. 9.47 billion respectively.