LINACLOTIDE | N202811 | ABBVIE INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| N.D. W. Va. | 2018-12-19 | Terminated 2018-12-27 | — | |
| D. Del. | 2018-03-29 | Terminated 2018-12-19 | — | |
| D. Del. | 2018-02-02 | Terminated 2020-01-17 | — | |
| D. Del. | 2018-01-30 | Terminated 2018-05-30 | — | |
Forest Laboratories, LLC et al v. Mylan Pharmaceuticals Inc. 10 patentsANDA 209564linaclotide | D. Del. | 2017-11-30 | Terminated 2018-08-30 | — |
Forest Laboratories, LLC et al v. Teva Pharmaceuticals USA, Inc. 10 patentsANDA 209568linaclotide | D. Del. | 2017-10-20 | Terminated 2018-05-14 | — |
| D. Del. | 2017-08-25 | Terminated 2018-05-07 | — | |
| D. Del. | 2017-06-30 | Terminated 2018-01-18 | — | |
Allergan Sales, LLC et al v. Teva Pharmaceuticals USA, Inc. et al 8 patentsANDA 211381linaclotide | D. Del. | 2016-11-30 | Terminated 2020-01-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Buchanan Ingersoll & Rooney PC ( on behalf of Synergy P... FDA-2018-P-0884 · 4 docket documents Buchanan Ingersoll & Rooney PC, on behalf of Synergy Pharmaceuticals Inc., filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA Commissioner require modification of the approved package insert for Linzess (linaclotide), NDA 202-811, to provide more complete and accessible adve | Other | 2018-02-27 | Denied | Synergy Pharmaceuticals Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.02
per ea
Lowest NADAC/Unit
$9.02
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00456120130LINZESS 145 MCG CAPSULE | $9.02 | EA | Brand | — | 2026-06-17 |
| 00456120230LINZESS 290 MCG CAPSULE | $9.02 | EA | Brand | — | 2026-06-17 |
| 00456120330LINZESS 72 MCG CAPSULE | $9.02 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| I-921 | Jun 12, 2026 | Expired |
| NPP | Nov 4, 2028 | Active |
| PED | May 4, 2029 | Active |
| NPP*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | May 4, 2029 | Active |
LINZESS (linaclotide) received pediatric exclusivity designation, extending its regulatory exclusivity expiration to May 2029.
New: LINZESS (LINACLOTIDE) — exclusivity NPP*PED exp 05/04/2029
LINZESS (linaclotide) received new patient population exclusivity designation expiring May 2029.
New: LINZESS (LINACLOTIDE) — exclusivity NPP exp 05/21/2029