morphine sulfate · Hikma · NDA 019916, 019917, 020631, 022195, 022207, 201517, 202515, 204223

Morphine Sulfate

Earliest generic entry, as listed · earliest of 13 marketed strengths

12 Mar 2034

10 of 13 marketed strengths have no unexpired patent or exclusivity listed.

Blocked by patent: US 9072781, US 9192608, US 9248229.

FDA has approved 1 generic application (ANDA) for Morphine Sulfate, though its earliest generic-entry date is 12 Mar 2034 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 3 unexpired

4 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 9072781	drug product · sets the listed date	12 Mar 2034	5 strengths · listed 13 Jul 2015
US 9192608	use U-43, U-55	12 Mar 2034	2 listing rows
US 9192608 listing row	use U-43 · sets the listed date	12 Mar 2034	5 strengths · listed 4 Dec 2015
US 9192608 listing row	use U-55 · sets the listed date	12 Mar 2034	5 strengths · listed 4 Dec 2015
US 9248229	drug product · sets the listed date	12 Mar 2034	5 strengths · listed 17 Feb 2016

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

Generic approved · ANDA 213892, Quagen · 022195-001Approved 7 Jul 2026Detected 25 Oct 2026Historical import

Products covered · 23

NDA · product	Form	Strength	Approved	Listed expiry
019916 · 001 · RLD · discontinued	injectable, injection	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	30 Oct 1992	open
019916 · 002 · RLD · discontinued	injectable, injection	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	27 Oct 2006	open
019917 · 001 · discontinued	injectable, injection	0.5MG/ML	30 Oct 1992	open
020631 · 001 · discontinued	injectable, injection	1MG/ML	3 Jul 1996	open
020631 · 002 · discontinued	injectable, injection	2MG/ML	3 Jul 1996	open
022195 · 001 · RLD	solution, oral	10MG/5ML	17 Mar 2008	open
022195 · 002 · RLD	solution, oral	20MG/5ML	17 Mar 2008	open
022195 · 003 · RLD	solution, oral	100MG/5ML	25 Jan 2010	open
022207 · 001 · RLD	tablet, oral	15MG	17 Mar 2008	open
022207 · 002 · RLD	tablet, oral	30MG	17 Mar 2008	open
201517 · 001 · discontinued	solution, oral	100MG/5ML	23 Jun 2011	open
202515 · 001 · RLD	injectable, injection	2MG/ML	14 Nov 2011	open
202515 · 002 · RLD	injectable, injection	4MG/ML	14 Nov 2011	open
202515 · 003 · RLD	injectable, injection	8MG/ML	14 Nov 2011	open
202515 · 004 · RLD	injectable, injection	10MG/ML	14 Nov 2011	open
202515 · 005 · RLD · discontinued	injectable, injection	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	14 Nov 2011	open
202515 · 006 · RLD	injectable, injection	50MG/ML	29 Apr 2021	open
204223 · 001 · RLD	solution, intramuscular, intravenous	2MG/ML (2MG/ML)	30 Oct 2013	12 Mar 2034
204223 · 002 · RLD	solution, intramuscular, intravenous	4MG/ML (4MG/ML)	30 Oct 2013	12 Mar 2034
204223 · 003 · RLD · discontinued	solution, intramuscular, intravenous	5MG/ML (5MG/ML)	30 Oct 2013	12 Mar 2034
204223 · 004 · RLD · discontinued	solution, intramuscular, intravenous	8MG/ML (8MG/ML)	30 Oct 2013	12 Mar 2034
204223 · 005 · RLD	solution, intramuscular, intravenous	10MG/ML (10MG/ML)	30 Oct 2013	12 Mar 2034
204223 · 006 · RLD · discontinued	solution, intramuscular, intravenous	1MG/0.5ML (1MG/0.5ML)	29 May 2026	open