CERLIPONASE ALFA | B761052 | BIOMARIN PHARM
Earliest legal licensure (12-year BPCIA floor)
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 (Apr. 27, 2017), 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) | Apr. 27, 2029 | 2y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jul. 24, 2031 | 5y remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("to slow the loss of ambulation in pediatric patients less than 3 years of age with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency, and to slow the loss of ambulation in asymptomatic pediatric patients 3 years of age and older with CLN2 disease, also known as TPP1 deficiency", protected through 2031-07-24) advances biosimilar entry from the full-label date to the estimated 12-year floor.
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| to slow the loss of ambulation in pediatric patients less than 3 years of age with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency, and to slow the loss of ambulation in asymptomatic pediatric patients 3 years of age and older with CLN2 disease, also known as TPP1 deficiency(label indication #1) | Jul. 24, 2031 | Apr. 27, 2029(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 · Jul. 24, 2031
Orphan-drug exclusivity runs past the licensure floor above, 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 at the floor date, 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 12428653(composition)· AI-discovered, not Purple-Book-listed · relevance 95/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 11 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12428653 | Formulation/compound | Sep. 25, 2045Active | Discovered |
| 12275948 | Formulation/compound | Apr. 10, 2045Active | Discovered |
| 12208144 | Method-of-use (carveable) | Jan. 23, 2045Active | Discovered |
| 12064485 | Formulation/compound | Aug. 15, 2044Active | Discovered |
| 11998643 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11591614 | Formulation/compound | Feb. 23, 2043Active | Discovered |
| 11505790 | Formulation/compound | Nov. 17, 2042Active | Discovered |
| 11262348 | Other | Feb. 24, 2042Active | Discovered |
| 11229687 | Formulation/compound | Jan. 20, 2042Active | Discovered |
| 11097015 | Formulation/compound | Aug. 19, 2041Active | Discovered |
| 11083741 | Method-of-use (carveable) | Aug. 5, 2041Active | Discovered |
| 10814008 | Other | Oct. 22, 2040Active | Discovered |
| 10788499 | Other | Sep. 24, 2040Active | Discovered |
| 10758598 | Formulation/compound | Aug. 27, 2040Active | Discovered |
| 10660972 | Formulation/compound | May. 21, 2040Active | Discovered |
Showing 15 of 28 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.
28 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.