DURAMORPH PF Drug Patent Profile

When do Duramorph Pf patents expire, and when can generic versions of Duramorph Pf launch?

Duramorph Pf is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in DURAMORPH PF is morphine sulfate. There are twenty-three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Duramorph Pf

A generic version of DURAMORPH PF was approved as morphine sulfate by HOSPIRA on September 30^th, 1992.

Summary for DURAMORPH PF

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	36
Patent Applications:	3,941
DailyMed Link:	DURAMORPH PF at DailyMed

Recent Clinical Trials for DURAMORPH PF

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indiana University	PHASE3
University of Miami	Phase 4
Indiana University	Phase 1/Phase 2

See all DURAMORPH PF clinical trials

Pharmacology for DURAMORPH PF

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for DURAMORPH PF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	DURAMORPH PF	morphine sulfate	INJECTABLE;INJECTION	018565-001	Sep 18, 1984	AP	RX	Yes	Yes
Hikma	DURAMORPH PF	morphine sulfate	INJECTABLE;INJECTION	018565-002	Sep 18, 1984	AP	RX	Yes	Yes

Last updated: July 6, 2026

Market dynamics and financial trajectory for DURAMORPH PF

Executive summary: DURAMORPH PF is an injectable opioid analgesic marketed in the U.S. (and likely other markets) for acute pain. Market dynamics are driven by (1) opioid prescribing controls and payer scrutiny, (2) hospital and emergency-department procurement cycles, (3) competitive pressure from other injectable morphine products and fentanyl/other alternatives, and (4) patent and exclusivity timing that governs generic and authorized-entrant entry risk. Financial trajectory typically tracks inpatient pain program demand, formulary access, and quota-based procurement.

This analysis cannot be completed with the required “hard data” (prices, revenue, shipment volumes, payer mix, launch timing, exclusivity and patent schedules, generic entry dates, and FDA/Orange Book status) because the underlying factual record for DURAMORPH PF’s exact NDC, listing status, and patent estate is not available in the provided information.