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MORPHINE SULFATE

NDA

MORPHINE SULFATE | N019916 | ICU MEDICAL INC

2 strengths0 unique patents0 unique exclusivities

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

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

Citizen Petitions

5 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lannett Company, Inc. and Cody Laboratories, Inc. (Alston & Bird LLP) - Citiz... FDA-2012-P-0053 · 5 docket documents Lannett Company Inc. and Cody Laboratories, Inc., through counsel at Alston & Bird, filed this citizen petition on January 12, 2012, under sections 201 and 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA affirm the grandfather status of morphine sulfate, including Lannett's Morph	Other	2012-02-16	Denied	—
Actavis Elizabeth, LLC (Alston & Bird LLP) - Citizen Petition FDA-2010-P-0082 · 23 docket documents Actavis Elizabeth LLC filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA establish specific bioequivalence standards for Abbreviated New Drug Applications seeking approval of extended-release morphine sulfate products that cite KADIAN as	505(q)	2010-02-22	Partially Denied	—
Patrick Foster - Citizen Petition FDA-2010-P-0012 · 7 docket documents Patrick Foster submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Drug Application for Morphine Sulfate Injection, 25 mg/mL, preservative free, in 50 mL and 100 mL single-use vials intended for dil	Other	2010-01-11	Withdrawn	—
Merchant & Gould P.C. - Citizen Petition FDA-2009-P-0388 · 6 docket documents Merchant & Gould P.C., on behalf of a client, filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Morphine Sulfate Concentrate Oral Solution 20mg/mL is suitable for submission in an ANDA, with the Reference Listed Dr	Other	2009-08-18	Withdrawn	—
Rakcczy Molino Mazzochi SIWIK LLP - Citizen Petition FDA-2008-P-0401 · 3 docket documents Rakoczy Molino Mazzocchi SIWIK LLP filed this suitability petition on July 10, 2008, under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare that an ANDA may be submitted for Morphine Sulfate Tablets in 5 mg, 10 mg, and 20 mg strengths, referencing Roxa	Other	2008-07-16	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

452 trials from ClinicalTrials.gov — 2 recruiting, 7 active, 300 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)NCT04214834	Phase 3	Active	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program	189	2020-09-28 → 2026-06-30
Cordotomy in Reducing Pain in Patients With Advanced Cancer NCT04119037	N/A	Active	M.D. Anderson Cancer Center	27	2019-09-16 → 2028-12-01
Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain NCT04011163	Phase 2/3	Active	KK Women's and Children's Hospital	40	2021-03-31 → 2025-12-31
Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia NCT02804022	Phase 2	Active	KK Women's and Children's Hospital	20	2016-12-29 → 2025-12-31
Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty NCT03774836	Phase 3	Active	Avenue Therapeutics, Inc.	360	2018-12-14 → 2019-06-30
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients NCT04188418	Phase 3	Active	M.D. Anderson Cancer Center	150	2020-10-23 → 2027-08-31
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy NCT03092011	Phase 4	Active	The Cooper Health System	69	2018-02-21 → 2026-12-01
Spinal Anesthesia For Enhanced Recovery After Liver Surgery NCT03715517	N/A	Recruiting	University of Manitoba	128	2018-10-04 → 2031-12-31
Post-Op Pain Control for Prophylactic Intramedullary Nailing.NCT03823534	Phase 3	Recruiting	St. Louis University	60	2019-02-20 → 2027-03-31
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine NCT04369950	Phase 4	Completed	The University of Texas Health Science Center, Houston	44	2020-05-11 → 2021-07-11

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

API Supply Chain4 active DMFs6 inactive

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

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

NORAMCO LLCMORPHINE SULFATE, USP

DMF 293172015

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

CODY LABORATORIES INCInactiveMORPHINE SULFATE, USP

DMF 280402014

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 9, 2019	SUPPL -19	View Letter (PDF)
Dec 20, 2016	SUPPL -16	View Letter (PDF)
Dec 20, 2016	SUPPL -17	View Letter (PDF)
Nov 6, 2006	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 30, 1992

No patent or exclusivity listings for this strength.

#002 — 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 27, 2006