Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2018-00120	7964580	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-25	—
IPR2018-00119	7964580	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-25	—
IPR2018-00121	8334270	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-26	—
IPR2018-00122	8334270	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-26	—
IPR2018-00123	8735372	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-11-09	—
IPR2018-00125	8633309	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-30	—
IPR2018-00126	9284342	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-11-02	—
IPR2018-00390	8889159	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-12-26	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 29, 2022	SUPPL -1	View Letter (PDF)
Jun 14, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 150MG;37.5MG/PACKET

RLD

14 patents2 exclusivities▴

PELLETS;ORAL | Approved: Jun 10, 2021

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7964580	Mar 26, 2029PED: Sep 26, 2029	PED	Yes	Yes	—
8334270	Mar 21, 2028PED: Sep 21, 2028	PED	Yes	Yes	—
8575135	Nov 16, 2032PED: May 16, 2033	PED	Yes	Yes	—
8580765	Mar 21, 2028PED: Sep 21, 2028	PED	Yes	Yes	—
8618076	Dec 11, 2030PED: Jun 11, 2031	PED	Yes	Yes	—
8633309	Mar 26, 2029PED: Sep 26, 2029	PED	Yes	Yes	—
8735372	Mar 21, 2028PED: Sep 21, 2028	PED	—	—	—
8889159	Mar 26, 2029PED: Sep 26, 2029	PED	—	Yes	—
8921341	Nov 16, 2032PED: May 16, 2033	PED	Yes	Yes	—
8940718	Nov 16, 2032PED: May 16, 2033	PED	Yes	Yes	—
9085573	Mar 21, 2028PED: Sep 21, 2028	PED	Yes	Yes	—
9284342	Sep 13, 2030PED: Mar 13, 2031	PED	Yes	Yes	—
11116783	Jan 30, 2034PED: Jul 30, 2034	PED	—	Yes	—
11707479	Jan 30, 2034PED: Jul 30, 2034	PED	—	Yes	—

Code	Date	Status
ODE-376	Jun 10, 2028	Active
PED	Dec 10, 2028	Active

#002 — 200MG;50MG/PACKET

RLD

14 patents2 exclusivities▾

PELLETS;ORAL | Approved: Jun 10, 2021