Last Updated: July 8, 2026

INFUMORPH Drug Patent Profile


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When do Infumorph patents expire, and what generic alternatives are available?

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

The generic ingredient in INFUMORPH 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 Infumorph

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

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Questions you can ask:
  • What is the 5 year forecast for INFUMORPH?
  • What are the global sales for INFUMORPH?
  • What is Average Wholesale Price for INFUMORPH?
Recent Clinical Trials for INFUMORPH

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

SponsorPhase
M.D. Anderson Cancer CenterEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
Abdelrady S Ibrahim, MDPhase 2

See all INFUMORPH clinical trials

Pharmacology for INFUMORPH
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for INFUMORPH

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma INFUMORPH morphine sulfate INJECTABLE;INJECTION 018565-003 Jul 19, 1991 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma INFUMORPH morphine sulfate INJECTABLE;INJECTION 018565-004 Jul 19, 1991 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for INFUMORPH

Last updated: March 12, 2026

What is INFUMORPH?

INFUMORPH is an injectable formulation of morphine, used primarily for managing severe pain in cancer and postoperative patients. It is a generic or branded opioid analgesic, depending on the manufacturer, and is regulated under controlled substances policies globally.

Market Size and Growth

The global opioid analgesics market, including INFUMORPH, was valued at approximately USD 12 billion in 2022. It is projected to grow at a CAGR of 3.5% from 2023 to 2030, reaching an estimated USD 15.5 billion by 2030. The growth drivers include increasing incidence of chronic pain conditions, expanding palliative care services, and rising approval of new formulations.

The market for injectable opioids accounts for roughly 35% of the total opioid analgesics market, positioning INFUMORPH within a significant segment focused on hospital settings.

Competitive Landscape

Major competitors include Purdue Pharma, fentanyl, morphine, hydromorphone, and other generic manufacturers. Key factors influencing competition are:

  • Regulatory approvals
  • Patent status
  • Manufacturing cost efficiency
  • Distribution channels

INFUMORPH’s market share remains limited due to the dominance of branded drugs like MS Contin (morphine sustained-release) and fentanyl patches, although the generic segment is expanding.

Regulatory Considerations

Regulation of INFUMORPH varies by country but generally includes strict controls due to its opioid classification. Major markets like the U.S., EU, and Japan require approval from agencies such as the FDA, EMA, or PMDA.

In the U.S., opioids face increasing scrutiny with policies aiming to curb misuse and diversion. The Drug Enforcement Agency (DEA) classifies INFUMORPH as Schedule II.

Pricing and Reimbursement

Pricing strategies for INFUMORPH are influenced primarily by the manufacturing costs and competitive bidding through hospital formularies. In the U.S., the average wholesale price (AWP) for injectable morphine ranges from USD 2 to USD 5 per vial.

Reimbursement policies are aligned with the drug class; Medicare and Medicaid typically cover opioid treatments with minimal co-payments, but policies vary globally.

Distribution Channels

Distribution primarily occurs via hospital pharmacies, specialty clinics, and pain management centers. Supply chain disruptions and regulatory hurdles impact volume and pricing.

Key Trends Influencing Market Trajectory

  • Shift to Non-Opioid Alternatives: Increasing adoption of non-opioid pain management options due to abuse potential.
  • Growth in Palliative Care: Aging populations in developed regions expand demand for injectable opioids like INFUMORPH.
  • Regulatory Stringency: Enhanced controls may increase compliance costs and limit new entries.
  • Manufacturing Consolidation: Mergers among generic drug manufacturers could influence supply stability and pricing.

Financial Outlook

For manufacturers, revenue from INFUMORPH depends on production capacity, market penetration, and competitive pricing. Approximate annual revenues can range from USD 50 million to USD 200 million for leading players, contingent on regional market share.

Profit margins are constrained by regulatory costs, with gross margins averaging 20-30%. Investment in R&D for reformulations or abuse-deterrent features could influence future growth.

Risks and Opportunities

Risks:

  • Regulatory tightening may limit sales.
  • Growing societal opposition to opioids could impact prescribing habits.
  • Supply chain vulnerabilities.

Opportunities:

  • Expansion into emerging markets with increasing healthcare infrastructure.
  • Development of formulations with reduced abuse potential.
  • Partnerships with healthcare providers to broaden access.

Conclusion

INFUMORPH operates in a mature, regulated segment of the pharmaceutical market with moderate growth prospects. Its financial trajectory hinges on regulatory developments, competitive dynamics, and the evolving landscape of pain management.


Key Takeaways

  • The global market for injectable opioids, including INFUMORPH, is projected to grow modestly, reaching USD 15.5 billion by 2030.
  • Competition centers around pricing, regulatory approval, and manufacturing costs; major players own limited market share in the generic segment.
  • Regulatory constraints, especially in the U.S. and EU, influence market access and sales volume.
  • Revenue varies widely, typically between USD 50 million to USD 200 million annually for leading suppliers.
  • Market growth is tempered by societal shifts toward non-opioid pain therapies, but opportunities exist in emerging markets and reformulation development.

FAQs

1. How does regulatory policy affect INFUMORPH sales?
Stringent regulation, especially in the U.S. and EU, limits prescribing and distribution, impacting sales volume and price.

2. Are there new formulations of INFUMORPH?
Development efforts focus on abuse-deterrent formulations to address addiction concerns, which could influence future sales.

3. What regions represent growth opportunities?
Emerging markets in Asia, Latin America, and parts of Africa offer increased demand due to expanding healthcare infrastructure.

4. How does market competition impact pricing?
Generic manufacturers drive down prices, making INFUMORPH more affordable but reducing margins.

5. What factors could accelerate the growth of INFUMORPH?
Increased acceptance of injectable opioids in palliative care and approval of new formulations could expand market size.


References

[1] MarketWatch. (2023). Opioid analgesics market size global forecast.
[2] Global Data. (2022). Pain management drugs and therapy insights.
[3] U.S. Food and Drug Administration. (2023). Controlled substance scheduling and regulations.
[4] IQVIA. (2022). Global prescription drug sales and market shares.
[5] IMS Health. (2021). Impact of regulatory changes on opioid prescribing patterns.

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