Biologic facts
MoleculeInsulin Lispro
No biosimilar to Insulin Lispro is licensed. The 12-year reference exclusivity date of 06/2008 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
The latest NADAC for INSULIN LISPRO 100 UNIT/ML KWIKPEN is $10.19 per mL (as of 10/28/2026).
Approved 1996
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
- 06/200812-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 Insulin Lispro profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $10.19 per mLINSULIN LISPRO 100 UNIT/ML KWIKPEN, as of 10/28/2026 CMS NADAC
- Latest recall
- 04/11/2023Class II, Insulin Lispro, Sanofi-Aventis U.S. LLC FDA enforcement
04Product
- First approved
- 1996 Purple Book
- Other brand names
- HumalogAdmelogLyumjev
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.