small molecule

XROMI

HYDROXYUREA

Loss of exclusivityDecember 2041latest FDA-listed patent expiry

CompanyNOVA LABORATORIES LTD

Drug detail

Brand name	XROMI
Active ingredient	HYDROXYUREA
Strength	100MG/ML
Dosage form	SOLUTION
Route	ORAL
Modality	Small molecule
FDA approval	April 2024
Marketing status	RX

Listed patents

Patent	Expires	Type
12409156	December 2041	product

Regulatory exclusivity

Code	Expires
ODE-470	April 2031
NP	April 2027

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

Drug detail

Listed patents

Regulatory exclusivity

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