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MORPHINE SULFATE

NDA

MORPHINE SULFATE | N022195 | HIKMA PHARMACEUTICALS USA INC

3 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

17 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -25	View Letter (PDF)
Dec 31, 2025	SUPPL -24	View Letter (PDF)
Nov 4, 2024	SUPPL -23	View Letter (PDF)
Dec 19, 2023	SUPPL -21	View Letter (PDF)
Jul 26, 2021	SUPPL -20	View Letter (PDF)
Jun 3, 2021	SUPPL -10	View Letter (PDF)
Mar 5, 2021	SUPPL -19	View Letter (PDF)
Oct 8, 2019	SUPPL -18	View Letter (PDF)
Oct 1, 2018	SUPPL -16	View Letter (PDF)
Oct 1, 2018	SUPPL -14	View Letter (PDF)
Dec 20, 2016	SUPPL -11	View Letter (PDF)
Apr 22, 2015	SUPPL -7	View Letter (PDF)
Jan 14, 2014	SUPPL -9	View Letter (PDF)
Jan 25, 2012	SUPPL -6	View Letter (PDF)
Oct 20, 2011	SUPPL -5	View Letter (PDF)
Jan 29, 2010	SUPPL -2	View Letter (PDF)
Mar 19, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG/5ML

RLDAA

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Mar 17, 2008

No patent or exclusivity listings for this strength.

#002 — 20MG/5ML

RLDAA

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Mar 17, 2008

#003 — 100MG/5ML

RLDAA

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Jan 25, 2010