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NDA

ALVIMOPAN | N021775 | CUBIST PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

Today

8946262

Feb. 12, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME CORP. v. TEVA PHARMACEUTICALS USA, INC. et al 3:2017cv06921 1 patentalvimopan	D.N.J.	2017-09-08	Terminated 2019-07-08	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

20 trials from ClinicalTrials.gov — 1 recruiting, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol NCT03216525	Phase 3	Recruiting	Brigham and Women's Hospital	136	2018-10-01 → 2024-06-01
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy NCT00708201	Phase 4	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	280	2009-03 → 2012-01
Trial of Alvimopan in Major Spine Surgery NCT02789111	Phase 4	Completed	University of Virginia	49	2016-06-01 → 2018-12-01
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects NCT00135577	Phase 2	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	67	2004-09 → 2007-04
Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain NCT00259922	Phase 3	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	485	2005-08
Accelerating Gastrointestinal Recovery NCT01704651	Phase 3	Completed	Jamie N. Bakkum-Gamez	146	2013-01 → 2015-10
Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication NCT00101998	Phase 2	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	233	2003-10-01 → 2006-05-01
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus NCT00388258	Phase 3	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	451	2001-03-01 → 2002-12-01
Alvimopan and Ileus in PSF NCT02218190	N/A	Completed	Washington University School of Medicine	31	2014-08 → 2019-01
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus NCT00388401	Phase 3	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	510	2002-01 → 2003-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVALVIMOPAN DIHYDRATE

DMF 305532016

MSN LIFE SCIENCES PRIVATE LTDALVIMOPAN DIHYDRATE

DMF 305632016

ALP PHARM BEIJING CO LTDInactiveALVIMOPAN DIHYDRATE

DMF 240352010

ALP PHARM BEIJING CO LTDInactiveALVIMOPAN DIHYDRATE

DMF 259082012

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jun 13, 2023	SUPPL -20	View Letter (PDF)
Nov 18, 2020	SUPPL -18	View Letter (PDF)
Dec 23, 2019	SUPPL -15	View Letter (PDF)
Oct 11, 2019	SUPPL -16	View Letter (PDF)
May 20, 2016	SUPPL -13	View Letter (PDF)
Oct 21, 2013	SUPPL -10	View Letter (PDF)
Oct 23, 2012	SUPPL -8	View Letter (PDF)
Oct 2, 2012	SUPPL -7	View Letter (PDF)
Jan 21, 2010	SUPPL -4	View Letter (PDF)
Feb 19, 2009	SUPPL -1	View Letter (PDF)
May 28, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

CAPSULE;ORAL | Approved: May 20, 2008

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8946262	Feb 12, 2030	—	—	—		—