AGALSIDASE BETA | B103979 | GENZYME
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Apr. 24, 2003 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Mar. 11, 2028 | 1y 7mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of pediatric patients 2 years of age up to patients 8 years of age with confirmed Fabry disease", protected through 2028-03-11) advances biosimilar entry from the full-label date to now (no remaining licensure floor).
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of pediatric patients 2 years of age up to patients 8 years of age with confirmed Fabry disease(label indication #2) | Mar. 11, 2028 | Open now(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Mar. 11, 2028
Orphan-drug exclusivity runs past the licensure floor, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest now, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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.
Latest formulation/compound patent 11998643(formulation)· AI-discovered, not Purple-Book-listed · relevance 87/100. This caps practical skinny-label entry; it does not move the licensure floor above.
3 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 30 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12391728 | Other | Aug. 14, 2045Active | Discovered |
| 12280011 | Other | Apr. 17, 2045Active | Discovered |
| 12203103 | Other | Jan. 16, 2045Active | Discovered |
| 11998643 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11912741 | Other | Feb. 22, 2044Active | Discovered |
| 11912739 | Other | Feb. 22, 2044Active | Discovered |
| 11884703 | Other | Jan. 25, 2044Active | Discovered |
| 11839861 | Other | Dec. 7, 2043Active | Discovered |
| 11685943 | Other | Jun. 22, 2043Active | Discovered |
| 11635363 | Other | Apr. 20, 2043Active | Discovered |
| 11434464 | Other | Sep. 1, 2042Active | Discovered |
| 11384342 | Other | Jul. 7, 2042Active | Discovered |
| 11357834 | Formulation/compound | Jun. 9, 2042Active | Discovered |
| 11306341 | Other | Apr. 14, 2042Active | Discovered |
| 11208644 | Formulation/compound | Dec. 23, 2041Active | Discovered |
Showing 15 of 33 patents (latest expirations).
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.
33 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.