Viewing data from:

MS CONTIN

NDA

MORPHINE SULFATE | N019516 | KNOA PHARMA LLC

5 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Aurolife Pharma LLC. FDA-2017-P-6307 Aurolife Pharma LLC submitted this citizen petition requesting that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes Pharmaceuticals LP (ANDA# A074769) as a reference standard for ANDA bioequivalence studies, because the original reference listed drug MS CONTIN (NDA# 0	505(q)	2017-10-30	Denied	Aurolife Pharma LLC.
Citizen Petition From Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) FDA-2014-P-0205 Purdue Pharma LP filed this citizen petition requesting that the FDA exercise its authority under Section 505(o) of the Federal Food, Drug and Cosmetic Act to impose safety labeling changes on immediate-release opioid analgesics parallel to those mandated for extended-release and long-acting opioid	Other	2014-02-25	Partially Denied	Purdue Pharma LP (Kleinfeld

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ms Contin (2023)

Total Spending

$1.1M

Total Claims

1,166

Beneficiaries

160

Avg Cost/Unit

$10.55

Spending Trend

$2.2M(2019)→$1.9M(2020)→$1.7M(2021)→$1.3M(2022)→$1.1M(2023)

YoY Change:-5.6%

5yr CAGR:-4.1%

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

API Supply Chain3 active DMFs5 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

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

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

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -63	View Letter (PDF)
Dec 29, 2025	SUPPL -62	View Letter (PDF)
Nov 4, 2024	SUPPL -60	View Letter (PDF)
Dec 19, 2023	SUPPL -58	View Letter (PDF)
Mar 5, 2021	SUPPL -57	View Letter (PDF)
Oct 8, 2019	SUPPL -55	View Letter (PDF)
Sep 28, 2018	SUPPL -53	View Letter (PDF)
Sep 28, 2018	SUPPL -54	View Letter (PDF)
May 31, 2017	SUPPL -52	View Letter (PDF)
Dec 20, 2016	SUPPL -49	View Letter (PDF)
Oct 4, 2016	SUPPL -50	View Letter (PDF)
Apr 22, 2016	SUPPL -47	View Letter (PDF)
Jun 29, 2015	SUPPL -46	View Letter (PDF)
Oct 30, 2014	SUPPL -43	View Letter (PDF)
Aug 20, 2014	SUPPL -44	View Letter (PDF)
Apr 17, 2014	SUPPL -42	View Letter (PDF)
Apr 16, 2013	SUPPL -38	View Letter (PDF)
Jul 11, 2012	SUPPL -36	View Letter (PDF)
Jul 11, 2012	SUPPL -37	View Letter (PDF)
May 14, 2010	SUPPL -34	View Letter (PDF)
May 29, 2007	SUPPL -30	View Letter (PDF)
Jun 9, 2004	SUPPL -19	View Letter (PDF)
Aug 14, 2003	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 30MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 29, 1987

No patent or exclusivity listings for this strength.

#002 — 60MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 8, 1988

#003 — 15MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 12, 1989

#004 — 100MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 16, 1990

#005 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 8, 1993

Change History (10)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

KNOA PHARMA replaced PURDUE PHARMA LP as the applicant for MS CONTIN (morphine sulfate) NDA 019516.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

KNOA PHARMA LLC becomes the listed applicant for MS Contin (morphine sulfate) extended-release tablets, replacing Purdue Pharma LP as the NDA 019516 holder.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant7/1/2026

MS CONTIN (morphine sulfate) NDA 019516 applicant changed from Purdue Pharma LP to KNOA Pharma.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

KNOA PHARMA LLC became the listed applicant for MS CONTIN (morphine sulfate) NDA 019516, replacing PURDUE PHARMA LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant Full Name7/1/2026

KNOA Pharma LLC became the applicant for MS Contin (morphine sulfate) NDA 019516, replacing Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant7/1/2026

KNOA PHARMA replaced PURDUE PHARMA LP as the applicant for MS CONTIN (morphine sulfate) extended-release tablets under NDA 019516.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

KNOA PHARMA LLC became the applicant for MS CONTIN (morphine sulfate) NDA 019516, replacing PURDUE PHARMA LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant7/1/2026

KNOA PHARMA replaced PURDUE PHARMA LP as the applicant for MS CONTIN (morphine sulfate) extended-release tablets under NDA 019516.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant7/1/2026

KNOA PHARMA acquired NDA 019516 for MS CONTIN (morphine sulfate) from Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

MS CONTIN (morphine sulfate) NDA 019516 applicant changed from Purdue Pharma LP to KNOA Pharma LLC.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC