MESALAMINE | N021252 | ABBVIE INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2017-08-11 | Terminated 2017-09-14 | — | |
Aptalis Pharma US, Inc. et al v. Delcor Asset Corporation et al 3 patentsANDA 208362mesalamine | D. Del. | 2015-12-27 | Terminated 2016-04-19 | — |
APTALIS PHARMA US, INC. et al v. DELCOR ASSET CORPORATION et al 3 patentsANDA 208362mesalamine | D.N.J. | 2015-12-23 | Terminated 2016-04-20 | — |
| D.N.J. | 2013-07-05 | Terminated 2015-11-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Aptalis Pharma US, Inc. - Citizen Petition FDA-2013-P-1287 · 4 docket documents Aptalis Pharma US, Inc. filed this citizen petition on October 15, 2013, under Sections 505 and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA refuse to receive or approve any abbreviated new drug application for a generic version of Canasa mesalamine rectal suppositorie | 505(q) Stay Request | 2013-11-14 | Denied | — |
Axcan Scandipharm, Inc. - Citizen Petition FDA-2007-P-0010 · 24 docket documents Axcan Scandipharm, Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require all manufacturers of generic CANASA (mesalamine) rectal suppositories to conduct adequate and well-controlled clinical safety and effectiveness trials dem | 505(q) | 2008-05-21 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$37.09
per ea
Lowest NADAC/Unit
$37.09
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 58914050156CANASA 1,000 MG SUPPOSITORY | $37.09 | EA | Brand | $1.33 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.