ADALIMUMAB | B125057 | ABBVIE INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 31, 2002 — 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 | Feb. 24, 2028 | 1y 7mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.", protected through 2028-02-24) 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 moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.(label indication #8) | Feb. 24, 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 · Feb. 24, 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 9950066(formulation)· AI-discovered, not Purple-Book-listed · relevance 95/100. This caps practical skinny-label entry; it does not move the licensure floor above.
84 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 9950066 | Formulation/compound | Apr. 19, 2038Active | Discovered |
| 9738714 | Formulation/compound | Aug. 17, 2037Active | Discovered |
| 9610301 | Formulation/compound | Mar. 30, 2037Active | Discovered |
| 9605064 | Method-of-use (carveable) | Mar. 23, 2037Active | Discovered |
| 9399061 | Method-of-use (carveable) | Jul. 21, 2036Active | Discovered |
| 9365645 | Other | Jun. 9, 2036Active | Discovered |
| 9334320 | Method-of-use (carveable) | May. 5, 2036Active | Discovered |
| 9315573 | Formulation/compound | Apr. 14, 2036Active | Discovered |
| 9295725 | Formulation/compound | Mar. 24, 2036Active | Discovered |
| 9289497 | Formulation/compound | Mar. 17, 2036Active | Discovered |
| 9272042 | Formulation/compound | Feb. 25, 2036Active | Discovered |
| 9255143 | Other | Feb. 4, 2036Active | Discovered |
| 9220781 | Formulation/compound | Dec. 24, 2035Active | Discovered |
| 9193787 | Other | Nov. 19, 2035Active | Discovered |
| 9114166 | Formulation/compound | Aug. 20, 2035Active | Discovered |
Showing 15 of 91 patents (latest expirations).
Approved Biosimilars
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 192 AI-discovered patents by relevance.
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2017-01987 | 8911737 | IPR | Sandoz Inc. | Institution Denied | 2017-08-21 | — |
| IPR2017-01988 | 8974790 | IPR | Sandoz Inc. | Institution Denied | 2017-08-21 | — |
| IPR2017-02106 | 9067992 | IPR | Sandoz Inc. | Terminated-Settled | 2017-09-14 | — |
| IPR2017-01009 | 9085619 | IPR | Coherus BioSciences, Inc. | Institution Denied | 2017-03-02 | — |
| IPR2017-01008 | 9085619 | IPR | Coherus BioSciences, Inc. | Institution Denied | 2017-03-02 | — |
| IPR2017-00827 | 9085619 | IPR | Coherus BioSciences Inc. | Terminated | 2017-01-31 | — |
| IPR2017-00823 | 9085619 | IPR | Coherus BioSciences, Inc. | Institution Denied | 2017-01-31 | — |
| IPR2017-00822 | 9085619 | IPR | Coherus BioSciences, Inc. | Institution Denied | 2017-01-31 | — |
| IPR2017-00826 | 9085619 | IPR | Coherus BioSciences, Inc. | Terminated | 2017-01-31 | — |
| IPR2017-02105 | 9090689 | IPR | Sandoz Inc. | Terminated-Settled | 2017-09-14 | — |
| IPR2018-00156 | 9187559 | IPR | Sandoz Inc. | Institution Denied | 2017-11-06 | — |
| IPR2018-00002 | 9512216 | IPR | Sandoz Inc. | Institution Denied | 2017-10-02 | — |
| IPR2017-01824 | 9512216 | IPR | Sandoz Inc. | Institution Denied | 2017-07-20 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| N.D. Ill. | 2021-10-22 | Terminated 2021-11-05 | — | |
| N.D. Ill. | 2021-05-28 | Terminated 2022-03-09 | — | |
| E.D. Va. | 2021-05-11 | Terminated 2021-10-22 | — | |
| N.D. Ill. | 2021-04-27 | Terminated 2022-03-09 | — | |
| D.N.J. | 2018-08-10 | Terminated 2018-10-16 | — | |
| D. Del. | 2017-08-02 | Terminated 2019-05-15 | — | |
| D. Del. | 2016-08-04 | Terminated 2017-09-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Abbott Laboratories (Covington & Burling LLP) - Citizen Petition FDA-2012-P-0317 · 5 docket documents Abbott Laboratories, through counsel Covington & Burling LLP, filed this citizen petition under 21 C.F.R. § 10.30 and section 351 of the Public Health Service Act requesting that FDA confirm it will not accept for filing, file, approve, or discuss any application or investigational new drug applicat | 505(q) | 2012-05-08 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.