AZELAIC ACID | N207071 | LEO PHARMA AS
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-07-09 | Terminated 2019-10-17 | — | |
| D. Del. | 2019-02-01 | Terminated 2020-03-27 | — | |
| D. Del. | 2018-11-27 | Terminated 2019-04-02 | — | |
| D. Del. | 2018-02-15 | Terminated 2019-04-02 | — | |
LEO Pharma A/S et al. v. Teva Pharmaceuticals USA, Inc. 6 patentsANDA 210928azelaic acid | D. Del. | 2018-01-03 | Terminated 2019-10-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Intendis, Inc. (Foley & Lardner LLP) - Citizen Petition FDA-2011-P-0227 · 4 docket documents Intendis, Inc. filed this citizen petition under sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA issue a timely response to Intendis' August 2010 comments on the May 2010 Draft Guidance on Azelaic Acid, stay the review and approval of any pendi | 505(q) Stay Request | 2011-04-11 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.33
per gm
Lowest NADAC/Unit
$8.33
per gm
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50222030350FINACEA 15% FOAM | $8.33 | GM | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.