Testing version — LOERadar is in active testing. Features and data may change.
RETACRIT (EPOETIN ALFA-EPBX) | LOERadar
RETACRIT
Biosimilar
EPOETIN ALFA-EPBX | B125545 | HOSPIRA INC
5 products0 Purple Book patents1 biosimilar
Biologic LOEBiosimilar competition
1 approved biosimilar
Earliest legal licensure (12-year BPCIA floor)
May 15, 2030(1399 days remaining)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (May. 15, 2018), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
Scenario
Date
Status
Controlling
Best-skinny entry (floor)
May. 15, 2030
3y 10mo remaining
12-year RPE floor (non-carveable)
Full-label entry
May. 15, 2030
3y 10mo remaining
12-year RPE floor
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
Marketing-entry ceiling (litigation risk)
Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.
Dec. 26, 20446738 days remaining
Latest formulation/compound patent 12178873(formulation)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.