Viewing data from:

ARYMO ER

NDA

MORPHINE SULFATE | N208603 | ZYLA LIFE SCIENCES US INC

3 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

2033

Today

9044402

Jul. 1, 2033

9549899

Jul. 1, 2033

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
Egalet US, Inc. et al v. Teva Pharmaceuticals USA, Inc. 1:2018cv00505	D. Del.	2018-04-04	Terminated 2018-10-30	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

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

6 letters from Drugs@FDA

Date	Submission	Document
Oct 8, 2019	SUPPL -5	View Letter (PDF)
Oct 17, 2018	SUPPL -1	View Letter (PDF)
Oct 1, 2018	SUPPL -3	View Letter (PDF)
Oct 1, 2018	SUPPL -4	View Letter (PDF)
May 31, 2017	SUPPL -2	View Letter (PDF)
Jan 9, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 15MG

RLD

2 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 9, 2017

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9044402	Jul 1, 2033	—	—	Yes		—
9549899	Jul 1, 2033	—	—	Yes		—

#002 — 30MG

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 9, 2017

#003 — 60MG

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 9, 2017