biologic

Engerix-B

Hepatitis B Vaccine (Recombinant)

Loss of exclusivityAugust 2001projected — 12-year biologic exclusivity estimate
CompanyGlaxoSmithKline Biologicals

Drug detail

Brand nameEngerix-B
Active ingredientHepatitis B Vaccine (Recombinant)
Strength20UG/ML
Dosage formInjection
RouteIntramuscular
ModalityBiologic
FDA approvalAugust 1989
Marketing statusRx

Source: FDA Purple Book, layered on the CliffBio company graph. Cliff dates are the projected — 12-year biologic exclusivity estimate; estimates are projections, not legal advice.

Engerix-B patent cliff — loss of exclusivity August 2001 | CliffBio