LUBIPROSTONE | N021908 | SUCAMPO PHARMA AMERICAS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2020-01-28 | Terminated 2020-11-13 | — | |
SUCAMPO AG et al v. SUN PHARMACEUTICAL INDUSTRIES, LTD. et al 7 patentsANDA 212292lubiprostone | D.N.J. | 2018-10-30 | Terminated 2020-07-01 | — |
SUCAMPO AG et al v. TEVA PHARMACEUTICAL INDUSTRIES LTD. et al 9 patentsANDA 209920lubiprostone | D.N.J. | 2017-09-25 | Terminated 2018-09-19 | — |
SUCAMPO PHARMA, LLC et al v. AMNEAL PHARMACEUTICALS LLC 5 patentsANDA 209450lubiprostone | D.N.J. | 2017-04-13 | Terminated 2018-07-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Sucampo Pharma Americas, LLC FDA-2014-P-0144 · 3 docket documents Sucampo Pharma Americas, LLC filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA revise its draft bioequivalence criteria for lubiprostone capsules and apply the revised criteria to any abbreviated new drug application listing | 505(q) | 2014-01-31 | Denied | Sucampo Pharma Americas, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$6.47
per ea
Lowest NADAC/Unit
$0.6039
per ea
Brand NDCs
2
Generic NDCs
8
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 23635050860AMITIZA 8 MCG CAPSULE | $6.47 | EA | Brand | $0.6039 | 2026-04-22 |
| 23635052460AMITIZA 24 MCG CAPSULE | $6.45 | EA | Brand | $0.6460 | 2026-04-22 |
| 43598016860LUBIPROSTONE 24 MCG CAPSULE | $0.6460 | EA | Generic | — | 2026-06-17 |
| 63304035260LUBIPROSTONE 24 MCG CAPSULE | $0.6460 | EA | Generic | — | 2026-06-17 |
| 00254302902LUBIPROSTONE 24 MCG CAPSULE | $0.6460 | EA | Generic | — | 2026-06-17 |
| 69339016317LUBIPROSTONE 24 MCG CAPSULE | $0.6460 | EA | Generic | — | 2026-06-17 |
Showing 6 of 10 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.