SOMATROGON-GHLA | B761184 | PFIZER IRELAND PHARMACEUTICALS
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jun. 27, 2023 — 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 | Jun. 27, 2030 | 3y 7mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2030-06-27) 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 aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone(label indication #1) | Jun. 27, 2030 | 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 · Jun. 27, 2030
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 9895417(composition)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
7 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 5 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 9895417 | Formulation/compound | Feb. 15, 2038Active | Discovered |
| 9708383 | Formulation/compound | Jul. 13, 2037Active | Discovered |
| 9242011 | Formulation/compound | Jan. 21, 2036Active | Discovered |
| 9187546 | Formulation/compound | Nov. 12, 2035Active | Discovered |
| 9067977 | Formulation/compound | Jun. 25, 2035Active | Discovered |
| 8940504 | Other | Jan. 22, 2035Active | Discovered |
| 8916360 | Formulation/compound | Dec. 18, 2034Active | Discovered |
| 8859731 | Method-of-use (carveable) | Oct. 9, 2034Active | Discovered |
| 8586532 | Method-of-use (carveable) | Nov. 14, 2033Active | Discovered |
| 8158771 | Other | Apr. 12, 2032Active | Discovered |
| 7276590 | Other | Sep. 27, 2027Active | Discovered |
| 7235638 | Formulation/compound | Jun. 21, 2027Active | Discovered |
| 6933136 | Other | Aug. 18, 2025Expired | Discovered |
| 6566490 | Other | May. 15, 2023Expired | Discovered |
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.
14 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.