Trial #	Patent	Type	Petitioner	Status	Filed	Decision
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
IPR2023-00016	7041786	IPR	MSN Laboratories Private Ltd. et al.	Final Written Decision - Appealed	2022-10-12	2026-01-27

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Bausch Health Ireland Limited et al v. Mylan Pharmaceuticals Inc. 1:2025cv00003 1 patentANDA 215686plecanatide	WVND	2025-01-13	Terminated 2025-05-14	—
BAUSCH HEALTH IRELAND LIMITED et al v. AUROBINDO PHARMA LIMITED et al 2:2023cv00170 8 patentsANDA 217007plecanatide	D.N.J.	2023-01-12	Terminated 2023-10-30	—
BAUSCH HEALTH IRELAND LIMITED et al v. MSN LABORATORIES PRIVATE LTD. et al 2:2021cv10057 8 patentsANDA 215780plecanatide	D.N.J.	2021-04-22	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Trulance (2023)

Total Spending

$119.3M

Total Claims

148,020

Beneficiaries

41,836

Avg Cost/Unit

$18.72

Spending Trend

$30.9M(2019)→$48.1M(2020)→$71.7M(2021)→$88.9M(2022)→$119.3M(2023)

YoY Change:+7.4%

5yr CAGR:+7.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDPLECANATIDE

DMF 340492019

MATRIX PHARMACORP PRIVATE LTDPLECANATIDE

DMF 342272019

ALP PHARM BEIJING CO LTDPLECANATIDE

DMF 354392020

AURO PEPTIDES LTDPLECANATIDE

DMF 363212021

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDPLECANATIDE

DMF 414932025

HYBIO PHARMACEUTICAL CO LTDPLECANATIDE

DMF 420622025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Apr 14, 2021	SUPPL -11	View Letter (PDF)
Feb 11, 2021	SUPPL -7	View Letter (PDF)
Dec 8, 2020	SUPPL -10	View Letter (PDF)
Jul 26, 2018	SUPPL -2	View Letter (PDF)
Jan 30, 2018	SUPPL -1	View Letter (PDF)
Jan 23, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG

RLD

10 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 19, 2017

Patents (10)

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	—	—