PEMBROLIZUMAB | B125514 | MERCK SHARP DOHME
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 (Sep. 4, 2014), 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) | Sep. 4, 2026 | 1mo 19d remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jan. 25, 2031 | 4y 6mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen and other than sorafenib", protected through 2031-01-25) 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 |
|---|---|---|
| treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen and other than sorafenib | Jan. 25, 2031 | Nov. 16, 2030(next orphan wall) |
| for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, excluding patients covered by Keytruda's previous indications for gastric or GEJ adenocarcinoma | Nov. 16, 2030 | Oct. 31, 2030(next orphan wall) |
| treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC) | Oct. 31, 2030 | Dec. 3, 2028(next orphan wall) |
| adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection, and adjuvant treatment of pediatric (12 years and older) patients with Stage III melanoma following complete resection(label indication #2) | Dec. 3, 2028 | Mar. 22, 2028(next orphan wall) |
| treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation, excluding patients covered by Keytruda�s previously approved indication for esophageal cancer | Mar. 22, 2028 | Oct. 14, 2027(next orphan wall) |
| treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed after 1 or 2 lines of therapy; and treatment of pediatric patients with cHL that has relapsed after 2 lines of therapy(label indication #14) | Oct. 14, 2027 | Sep. 4, 2026(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 · Jan. 25, 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 12441780(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
27 formulation/compound (cap skinny entry) · 20 method-of-use (carveable — gate nothing) · 3 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12441780 | Formulation/compound | Oct. 9, 2045Active | Discovered |
| 12410252 | Formulation/compound | Sep. 4, 2045Active | Discovered |
| 12358984 | Formulation/compound | Jul. 10, 2045Active | Discovered |
| 12358986 | Method-of-use (carveable) | Jul. 10, 2045Active | Discovered |
| 12310999 | Formulation/compound | May. 22, 2045Active | Discovered |
| 12291570 | Formulation/compound | May. 1, 2045Active | Discovered |
| 12286483 | Method-of-use (carveable) | Apr. 24, 2045Active | Discovered |
| 12258407 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12144839 | Method-of-use (carveable) | Nov. 14, 2044Active | Discovered |
| 12110330 | Formulation/compound | Oct. 3, 2044Active | Discovered |
| 12037395 | Formulation/compound | Jul. 11, 2044Active | Discovered |
| 11932693 | Formulation/compound | Mar. 14, 2044Active | Discovered |
| 11918648 | Formulation/compound | Feb. 29, 2044Active | Discovered |
| 11899017 | Other | Feb. 8, 2044Active | Discovered |
| 11718668 | Method-of-use (carveable) | Aug. 3, 2043Active | Discovered |
Showing 15 of 50 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.
Top 50 of 173 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| C.D. Cal. | 2016-07-07 | Terminated 2017-05-05 | — | |
| D.N.J. | 2016-01-22 | Terminated 2017-03-29 | — | |
| D. Nev. | 2015-10-28 | Terminated 2016-02-24 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.