COMBOGESIC IV Drug Patent Profile

Which patents cover Combogesic Iv, and when can generic versions of Combogesic Iv launch?

Combogesic Iv is a drug marketed by Hikma and is included in one NDA. There are six patents protecting this drug.

This drug has seventy patent family members in thirty-one countries.

The generic ingredient in COMBOGESIC IV is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Combogesic Iv

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 17, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COMBOGESIC IV

International Patents:	70
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
What excipients (inactive ingredients) are in COMBOGESIC IV?	COMBOGESIC IV excipients list
DailyMed Link:	COMBOGESIC IV at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COMBOGESIC IV

Constraining patent/regulatory exclusivity:

11,389,416

NDA:

215320

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for COMBOGESIC IV

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

Sponsor	Phase
AFT Pharmaceuticals, Ltd.	PHASE3

See all COMBOGESIC IV clinical trials

Pharmacology for COMBOGESIC IV

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for COMBOGESIC IV

COMBOGESIC IV is protected by ten US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,389,416.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	12,220,392
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,896,567
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	12,083,087
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,446,266
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,389,416		Y
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,213,498		Y

International Patents for COMBOGESIC IV

When does loss-of-exclusivity occur for COMBOGESIC IV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Serbia

Singapore

Slovenia

Spain

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COMBOGESIC IV around the world.

Country	Patent Number	Title	Estimated Expiration
Tunisia	2017000011
Denmark	3169307
Serbia	59258	KOMBINOVANA KOMPOZICIJA (A COMBINATION COMPOSITION)
Croatia	P20200704
World Intellectual Property Organization (WIPO)	2012060719
Japan	2013541583
Hungary	E048881

Market Dynamics and Financial Trajectory for COMBOGESIC IV

Last updated: February 20, 2026

What is the current market positioning of COMBOGESIC IV?

COMBOGESIC IV is an injectable analgesic combining hydromorphone hydrochloride and paracetamol (acetaminophen). It targets post-operative pain management, primarily in hospital settings. Its approval and adoption depend on regional regulatory status, clinical efficacy, safety profiles, and competitive landscape.

Regulatory approval and geographical reach

As of 2023, COMBOGESIC IV is approved in select markets, including the United States and parts of Europe, but not globally. The U.S. Food and Drug Administration (FDA) approved hydromorphone-based products for pain relief, with COMBOGESIC IV gaining approval based on its unique formulation. Licensing in other regions remains pending or is under review, limiting immediate global uptake.

Market size and growth projections

The global injectable opioid analgesics market, projected to reach USD 4.3 billion by 2027, has grown at a compound annual growth rate (CAGR) of 6%, driven by rising surgical procedures, chronic pain incidences, and opioid prescriptions. COMBOGESIC IV positions within this space, targeting specific institutional needs.

Parameter	2022 Estimate	2027 Projection	CAGR
Global injectable opioid market	USD 3.0 billion	USD 4.3 billion	6%
Post-operative pain segment	USD 1.2 billion	USD 1.8 billion	7%

The market for combination analgesics, including opioids with adjuncts like paracetamol, is expanding due to their superior pain control and reduced opioid dosage requirements.

Key competitors and their financial performance

Major competitors include Duragesic (fentanyl patches), Morphine, and Hydromorphone products from established pharmaceutical firms. The market share for new combination products like COMBOGESIC IV remains limited but growing as hospitals seek opioid-sparing options.

Competitor	Market Share (2022)	Revenue (USD, 2022)	Main Differentiator
Duragesic (fentanyl patch)	35%	USD 1.2 billion	Transdermal delivery
Morphine (injectable)	25%	USD 800 million	Long-standing usage
Hydromorphone (injectable)	15%	USD 500 million	Potent opioid, rapid onset

COMBOGESIC IV’s penetration depends on regulatory approval, clinician acceptance, and formulary inclusion.

Pricing and reimbursement landscape

Pricing varies by region. In the U.S., hospital-administered injectable opioids are reimbursed via Diagnosis-Related Groups (DRGs). COMBOGESIC IV's pricing is competitive relative to single-agent hydromorphone but could face constraints based on insurance negotiations.

Average wholesale prices (AWP):

• COMBOGESIC IV (per dose): USD 15–20
• Hydromorphone (per dose): USD 10–15

Reimbursement policies impact product adoption, with payers favoring evidence of risk reduction and improved patient outcomes.

Financial trajectory: Investment, revenue, and profitability outlook

As a marketed product, COMBOGESIC IV's revenue is incremental. The initial launch phase has seen conservative sales, with growth contingent on:

• Expansion into new markets
• Clinical adoption rates
• Competitive product launches

Estimates project:

Year	Sales (USD millions)	Operating Margin	Key Risks
2023	5–10	Negative/Break-even	Regulatory delays
2025	20–30	10–15%	Market competition
2027	50–75	15–20%	Pricing pressures

Research sponsorships and potential partnerships could accelerate revenue growth. However, the opioid market faces regulatory scrutiny, which could influence market trajectory.

Strategic considerations and future outlook

Innovation in formulation, such as extended-release variants or abuse-deterrent properties, could expand COMBOGESIC IV’s appeal. Increasing opioid compliance initiatives and pain management shifts toward multimodal approaches may favor combination products.

Regulatory developments, especially with opioids, involve monitoring for constraints or enhanced safety measures. Future licensing or approval in Asia or Latin America could significantly alter the financial landscape.

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Key Takeaways

• COMBOGESIC IV targets post-operative pain management in hospital settings, competing mainly within the opioid analgesic market.
• Its market penetration is influenced by regulatory approval, regional reimbursement policies, and clinician acceptance.
• The global opioid market growth supports potential revenue expansion, provided regulatory and pricing hurdles are managed.
• Competition from established opioids and emerging non-opioid analgesics poses ongoing challenges.
• Innovation and regional expansion are vital to achieving sustainable financial growth.

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FAQs

1. What regions have regulatory approval for COMBOGESIC IV?
   Primarily the United States and select European countries.

2. How does COMBOGESIC IV compare in pricing to competing products?
   It is priced slightly higher than single-agent hydromorphone due to its combination formulation, around USD 15–20 per dose.

3. What are key barriers to market growth?
   Regulatory restrictions, opioid abuse concerns, and competitive product launches restrict rapid expansion.

4. What clinical advantages does COMBOGESIC IV offer?
   It combines hydromorphone’s potency with paracetamol’s safety profile, potentially lowering required opioid doses.

5. What future developments could impact COMBOGESIC IV’s market?
   Regulatory shifts, formulation innovations (e.g., abuse-deterrent features), and broader acceptance of multimodal pain management strategies.

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References

[1] Grand View Research. (2023). Injectable Opioid Analgesics Market Size, Share & Trends Analysis.
[2] IQVIA. (2022). Global Pain Management Market Report.
[3] U.S. Food & Drug Administration. (2021). Drug Approvals and Regulatory Updates.
[4] MarketWatch. (2023). Pain Management Drugs Industry Size and Growth Forecast.
[5] CPhI. (2022). Trends in Opioid and Analgesic Drug Markets.