PLECANATIDE | N208745 | SALIX PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2023-00016 | 7041786 | IPR | MSN Laboratories Private Ltd. et al. | Final Written Decision - Appealed | 2022-10-12 | 2026-01-27 |
| IPR2022-00722 | 7041786 | IPR | Mylan Pharmaceuticals Inc. et al. | Final Written Decision - Appealed | 2022-03-21 | 2026-01-27 |
| IPR2022-01102 | 9610321 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2022-06-10 | 2023-01-04 |
| IPR2022-01103 | 9616097 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2022-06-10 | 2023-01-04 |
| IPR2022-01104 | 9919024 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2022-06-10 | 2023-01-04 |
| IPR2022-01105 | 9925231 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2022-06-10 | 2023-01-04 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Bausch Health Ireland Limited et al v. Mylan Pharmaceuticals Inc. 1 patentANDA 215686plecanatide | N.D. W. Va. | 2025-01-13 | Terminated 2025-05-14 | — |
BAUSCH HEALTH IRELAND LIMITED et al v. AUROBINDO PHARMA LIMITED et al 8 patentsANDA 217007plecanatide | D.N.J. | 2023-01-12 | Terminated 2023-10-30 | — |
| N.D. W. Va. | 2022-09-01 | Terminated 2025-05-14 | — | |
| N.D. W. Va. | 2022-03-09 | Terminated 2025-05-14 | — | |
BAUSCH HEALTH IRELAND LIMITED et al v. MYLAN LABORATORIES LTD. et al 8 patentsANDA 215686plecanatide | D.N.J. | 2021-04-28 | Terminated 2022-03-08 | — |
BAUSCH HEALTH IRELAND LIMITED et al v. MSN LABORATORIES PRIVATE LTD. et al 8 patentsANDA 215780plecanatide | D.N.J. | 2021-04-22 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, PC FDA-2017-P-4409 · 5 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA require Synergy Pharmaceuticals to revise the approved package insert for Trulance (plecanatide), an NDA 208745 product approved January 19, 2017 for chronic idiopathic constipation in adults. The petitio | Other | 2017-07-25 | Partially Denied | Hyman, Phelps & McNamara, PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7041786 | Jan 30, 2028 | — | Yes | — | — | — |
| 9610321 | Sep 15, 2031 | — | — | — | — | |
| 9616097 | Aug 20, 2032 | — | — | Yes | — | — |
| 9919024 | Sep 15, 2031 | — | — | — | — | |
| 9925231 | Sep 15, 2031 | — | — | Yes | — | — |
| 10011637 | Jun 5, 2034 | — | Yes | — | — | — |
| 11142549 | Jun 5, 2034 | — | — | Yes | — | — |
| 11319346 | Mar 1, 2032 | — | — | Yes | — | — |
| 11834521 | Jun 5, 2034 | — | — | Yes | — | — |
| 12146003 | Jun 5, 2034 | — | — | Yes | — | — |