Lupin Gets USFDA Approval for Generic Pitolisant Tablets in the US

Indian pharmaceutical major Lupin Limited has received final approval from the US Food and Drug Administration for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths, expanding its portfolio of specialised generic medicines in the United States.

Lupin announced the approval on August 17, 2026, stating that its Abbreviated New Drug Application had received final clearance from the USFDA. The tablets are bioequivalent to Wakix, the reference medicine associated with Harmony Biosciences.

Used in Narcolepsy Treatment

Pitolisant is used in the treatment of excessive daytime sleepiness associated with narcolepsy, a neurological disorder that affects normal sleep-wake regulation.

Wakix was originally approved by the USFDA in 2019 for excessive daytime sleepiness in adults with narcolepsy. Its approved uses were subsequently expanded to cover additional indications and patient groups.

Lupin said its generic product has been cleared for the indications contained in its approved US labeling.

What the Approval Means

An Abbreviated New Drug Application allows a pharmaceutical company to market a generic version of an already approved medicine after demonstrating that the product meets FDA quality requirements and is bioequivalent to the reference drug.

The final approval therefore clears an important regulatory hurdle for Lupin’s Pitolisant product in the US market. However, the company has not yet announced a commercial launch date, pricing or expected revenue contribution from the medicine.

Approval Comes After Wakix Exclusivity Milestone

The timing is notable because FDA records show that the orphan-drug exclusivity covering Wakix for excessive daytime sleepiness in adults with narcolepsy expired on August 14, 2026.

Other Wakix indications retain later exclusivity periods, including cataplexy and certain pediatric uses. This means generic products may have different approved labeling depending on remaining regulatory protections.

Strengthening Lupin’s US Portfolio

The approval adds another specialised central nervous system product to Lupin’s extensive US generics business.

Lupin operates across more than 100 markets and maintains a significant presence in therapeutic areas including CNS disorders, respiratory diseases, cardiovascular conditions, diabetes and anti-infectives.

The Pitolisant approval strengthens that portfolio while giving Lupin an opportunity to participate in the emerging US generic market for a specialised narcolepsy treatment.

Official Sources

Lupin Limited — August 17, 2026: Official announcement confirming USFDA final approval for Pitolisant Tablets, 4.45 mg and 17.8 mg.

US Food and Drug Administration: Official records covering Wakix indications and regulatory exclusivity.