Bebulin (Factor IX Complex)

No biosimilar to Bebulin is licensed. The 12-year reference exclusivity date of 08/1982 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Bebulin was first approved by the FDA in 1970; the application holder is Baxalta US Inc.

Holder Baxalta US Inc.Approved 1970

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Data as of 10/31/2026

Reference exclusivityEndedEst. 08/1982; patents not in the Purple Book Biosimilars0 licensedNone licensed FDA shortageClearNot listedCurrent FDA list

01Exclusivity

When biosimilar competition can legally begin. The Purple Book lists reference exclusivity but not patents, which can protect a biologic longer.

Patents: Not listed in the Purple Book
Reference exclusivity: 08/198212-year estimate from first approval

02Competition

Biosimilars: No biosimilar approved

Every makerEach licensed product and biosimilar maker.

PrescribersWho prescribes it, from Medicare data.

Spend and safetyMedicare Part B spend and safety reports.

Available in the full Bebulin profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list

04Product

Application holder: Baxalta US Inc.
First approved: 1970
Other brand names: Profilnine Sd

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.