COLCHICINE | N204820 | HIKMA INTERNATIONAL PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-10-11 | Terminated 2023-11-15 | — | |
| D. Del. | 2023-03-02 | Terminated 2023-05-08 | — | |
| D. Del. | 2021-02-18 | Terminated 2021-08-17 | — | |
Hikma Pharmaceuticals USA Inc. et al v. Micro Labs Ltd. et al 5 patentsANDA 212880colchicine | D. Del. | 2019-05-10 | Terminated 2020-03-11 | — |
Hikma Pharmaceuticals USA Inc. et al v. Granules Pharmaceuticals, Inc., USA 5 patentsANDA 210757colchicine | D. Del. | 2018-01-12 | Terminated 2019-09-18 | — |
| D. Del. | 2014-10-03 | Terminated 2018-12-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services Inc FDA-2015-P-2807 · 5 docket documents Lachman Consultant Services Inc filed this citizen petition on July 29, 2015, requesting that the FDA designate MITIGARETM (colchicine) Capsules 0.6 mg under NDA 204820 held by Hikma International Pharmaceutical as a reference-listed drug in the Orange Book to enable submission of an abbreviated new | Other | 2015-08-04 | Granted | Lachman Consultant Services Inc |
Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Citizen Petition FDA-2012-P-1018 · 3 docket documents Mutual Pharmaceutical Company, Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act and associated regulations requesting that the FDA refrain from approving any Abbreviated New Drug Application for a generic colchicine product referencing its brand-name dru | 505(q) | 2012-10-04 | Denied | — |
Citizen Petition from Par Pharmaceutical FDA-2012-P-0632 · 5 docket documents Par Pharmaceutical submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the Commissioner determine that Colchicine Tablets in strengths of 0.3 mg, 1.2 mg, and 1.8 mg are suitable for submission as an ANDA, with Colcrys Tablets 0.6 mg | Other | 2012-06-15 | Partially Denied | Par Pharmaceutical |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$6.04
per ea
Lowest NADAC/Unit
$1.96
per ea
Brand NDCs
3
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59467031830MITIGARE 0.6 MG CAPSULE | $6.04 | EA | Brand | $1.96 | 2026-06-17 |
| 59467031801MITIGARE 0.6 MG CAPSULE | $6.04 | EA | Brand | $1.96 | 2026-06-17 |
| 59467031810MITIGARE 0.6 MG CAPSULE | $6.04 | EA | Brand | $1.96 | 2026-06-17 |
| 00904673204COLCHICINE 0.6 MG CAPSULE | $1.96 | EA | Generic | — | 2026-06-17 |
| 00143301801COLCHICINE 0.6 MG CAPSULE | $1.96 | EA | Generic | — | 2026-06-17 |
| 60687035825COLCHICINE 0.6 MG CAPSULE | $1.96 | EA | Generic | — | 2026-06-17 |
| 00143301810COLCHICINE 0.6 MG CAPSULE | $1.96 | EA | Generic | — | 2026-06-17 |
| 00143301830COLCHICINE 0.6 MG CAPSULE | $1.96 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.