Biologic facts

Brand

Dysport (AbobotulinumtoxinA)

No biosimilar to Dysport is licensed. The 12-year reference exclusivity date of 04/2021 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Dysport was first approved by the FDA in 2009; the application holder is Ipsen Biopharm Limited.

Holder Ipsen Biopharm LimitedApproved 2009

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
Purple Book
Reference exclusivity
04/202112-year estimate from first approval
Purple Book

02Competition

Biosimilars
No biosimilar approved
Purple Book
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 Dysport profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages

04Product

Application holder
Ipsen Biopharm Limited
Purple Book
First approved
2009
Purple Book

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