small molecule

KEMSTRO

BACLOFEN

Loss of exclusivity—loss of exclusivity

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Drug detail

Brand name	KEMSTRO
Active ingredient	BACLOFEN
Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Dosage form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Modality	Small molecule
FDA approval	October 2003
Marketing status	DISCN

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the loss of exclusivity; estimates are projections, not legal advice.