Lupin's Secret US Weapon: 180-Day Exclusivity on New Drug - HUGE Market Opportunity Unlocked!

Author

Akshat Lakshkar | Whalesbook News Team

Detailed Coverage:

Indian pharmaceutical company Lupin has announced the launch of its generic Risperidone for extended-release injectable suspension in the United States. This new medication, available in 25 mg, 37.5 mg, and 50 mg single-dose vials, is bioequivalent and therapeutically equivalent to the reference drug Risperdal Consta LAI. A key highlight of this launch is the grant of 180-day CGT exclusivity in the US market, providing Lupin with a head start over competitors.

This launch marks a significant milestone as it is Lupin's first product to be developed using its subsidiary Nanomi BV's proprietary PrecisionSphere platform, designed for long-acting injectables (LAI). The drug is approved for treating schizophrenia in adults and for the maintenance treatment of bipolar disorder in adults. Market data from IQVIA estimates the combined sales for these dosages of Risperidone for extended-release injectable suspension to be USD 187 million in the US.

Impact: This launch is expected to positively impact Lupin Limited by increasing its revenue stream from the lucrative US market and strengthening its position in the complex injectable drug segment. The 180-day exclusivity provides a competitive edge, allowing Lupin to capture market share before other generics enter. It validates Lupin's investment in advanced drug delivery technologies like PrecisionSphere and Nanomi BV's capabilities. The company anticipates this will fuel further development of differentiated, complex products. Rating: 7/10

Difficult Terms: Generic Medication: A pharmaceutical drug that has the same chemical compound, dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use as a brand-name drug. Extended-release injectable suspension: A liquid medication designed to be injected into the body that is formulated to release its active ingredients slowly over an extended period. 180-day CGT exclusivity: A period of 180 days granted by the US FDA to the first generic drug applicant that files a patent challenge, preventing other generics from being approved during this time. CGT likely refers to 'Competitive Generic Therapy'. USFDA: United States Food and Drug Administration, the federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and other products. Bioequivalent: A drug that has the same active ingredient, dosage form, strength, and route of administration and performs in the same manner as a brand-name drug. Therapeutically equivalent: Drugs that are bioequivalent and have the same clinical effect and safety profile. Reference listed drug: The brand-name drug to which a generic drug's manufacturer must demonstrate bioequivalence and therapeutic equivalence. Long-acting injectables (LAI): Medications administered via injection that are designed to release their active ingredients slowly over a prolonged period, reducing the frequency of dosing.