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 October 17, 2026. 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:

NEW PRODUCT

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 NEW PRODUCT.

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
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
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			Y

International Patents for COMBOGESIC IV

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

Country	Patent Number	Title	Estimated Expiration
Tunisia	2017000011	AQUEOUS FORMULATION COMPRISING PARACETAMOL AND IBUPROFEN.
Portugal	2635269
Poland	3656377
Singapore	189319	A COMBINATION COMPOSITION
Denmark	2635269

Market Dynamics and Financial Trajectory for COMBOGESIC IV

Last updated: July 28, 2025

Introduction

COMBOGESIC IV, a combination analgesic formulation primarily comprising paracetamol (acetaminophen) and tramadol, has garnered increasing interest within the pharmaceutical landscape. Its intravenous (IV) delivery formulation caters to postoperative pain management and acute care settings, positioning it as a critical asset amid evolving pain management protocols. This analysis delineates the market dynamics influencing COMBOGESIC IV’s adoption, alongside its projected financial trajectory, informed by regulatory trends, competitive positioning, and healthcare sector shifts.

Market Landscape Overview

The global intravenous analgesics market is witnessing significant growth, driven by rising prevalence of acute and chronic pain, expanding surgical procedures, and the need for effective pain relief in hospitalized patients. The analgesics market is anticipated to grow at a compound annual growth rate (CAGR) of approximately 7% over the next five years, reaching an estimated valuation of $7.8 billion by 2028 [1].

COMBOGESIC IV competes within this dynamic environment, filling the niche for combination therapies that optimize pain control while minimizing opioid-related side effects. Notably, the focus on multimodal analgesia—using drugs like tramadol and paracetamol together—aligns with current clinical guidelines emphasizing opioid-sparing strategies [2].

Key Market Drivers

1. Growing Postoperative Pain Management Needs:
   The increase in complex surgical procedures globally amplifies demand for effective IV analgesics. COMBOGESIC IV’s rapid onset and dual mechanism of action make it suitable for managing moderate to severe pain in postoperative settings [3].

2. Shift Toward Multimodal Analgesia:
   Clinical guidelines promote combining analgesics to reduce opioid consumption and associated adverse effects [2]. COMBOGESIC IV fits into this paradigm, offering a synergistic approach that appeals to healthcare providers.

3. Regulatory and Reimbursement Environment:
   Regulatory agencies, such as the FDA and EMA, support formulations that enhance safety profiles. The rising emphasis on opioid alternatives seen in policies across North America and Europe encourages adoption of combination agents like COMBOGESIC IV.

4. Evolving Surgical Techniques and Healthcare Infrastructure:
   Advances in minimally invasive surgery increase the rate of procedures requiring effective IV analgesia. Healthcare infrastructure upgrades, especially in emerging markets, expand access to intravenous pain management options [4].

Market Challenges

• Cost Considerations:
  COMBOGESIC IV’s manufacturing complexity and patent status influence pricing strategies. High costs could limit use in price-sensitive markets.

• Regulatory Hurdles:
  Off-label prescribing or delays in approval processes across different jurisdictions may impede adoption.

• Competition:
  The presence of alternative IV analgesics, including opioids (morphine, fentanyl) and non-opioid agents (NSAIDs, acetaminophen alone), creates competitive pressure. Biosimilars and new molecular entities further fragment the market.

• Safety Concerns:
  Potential for tramadol dependence, serotonergic syndrome, and liver toxicity associated with paracetamol necessitate cautious prescribing, impacting market penetration.

Competitive Landscape

COMBOGESIC IV operates amidst a diverse array of analgesic options:

• Traditional opioids with well-established protocols.
• Non-opioid IV agents such as ketorolac.
• Other combination drugs in development or approved, like oxycodone with acetaminophen.

The regulatory approval status and clinician familiarity significantly influence market uptake. Partnerships with healthcare providers and pharmaceutical distributors are key to expanding its footprint.

Financial Trajectory

The financial outlook of COMBOGESIC IV hinges on several interrelated factors:

Revenue Potential

• Market Penetration Rate:
  Initial penetration may be modest, limited to key markets with early favorable approvals. However, with increasing clinical acceptance, revenue could grow exponentially, particularly if bundled within multimodal pain management protocols.

• Pricing Strategy:
  Premium pricing based on formulation advantages may be sustainable, provided safety profiles are maintained. Volume growth across hospitals and surgical centers would underpin revenue expansion.

• Regional Dynamics:
  North America and Europe represent mature markets with high healthcare expenditure and adoption rates. Emerging markets in Asia-Pacific, Latin America, and the Middle East offer vast potential due to increasing healthcare investments and surgical volume growth.

Cost Trajectories

• Manufacturing and R&D Costs:
  High initial investments in formulation development and regulatory approval inflate early costs. Economies of scale and process optimization are expected to reduce per-unit costs over time.

• Regulatory Compliance:
  Regular compliance with evolving safety and efficacy standards can incur ongoing expenses, but also elevate market credibility, enabling premium pricing.

Growth Projections

Analyses suggest that IV analgesic formulations akin to COMBOGESIC IV could experience a CAGR of 8-10% over the next five years, driven by increasing surgical volumes and adoption of multimodal analgesia [1]. If COMBOGESIC IV captures even 5-10% of this potential, revenues could reach several hundred million dollars by 2028.

Regulatory Environment Impact

The route to market success heavily depends on regulatory approvals. Approval processes are progressing variably across jurisdictions, with pivotal trials demonstrating safety and efficacy becoming central to approval. Strategic alliances with regional regulatory bodies and early engagement provide a competitive advantage.

Market Penetration Strategies

• Clinical Advocacy:
  Demonstrating superior safety and efficacy data to clinicians can increase adoption.

• Strategic Partnerships:
  Collaborations with healthcare institutions and insurers can facilitate reimbursement pathways.

• Education and Awareness:
  Initiatives targeting surgeons and anesthesiologists can bolster prescribing behaviors favoring COMBOGESIC IV.

Conclusion

COMBOGESIC IV's market dynamics favor a positive growth trajectory, buoyed by global trends in pain management and surgical care. Its financial success depends on regulatory milestones, clinical acceptance, competitive positioning, and regional market access. Strategic focus on clinical evidence, regulatory navigation, and market penetration will determine its long-term financial impact.

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Key Takeaways

• COMBOGESIC IV benefits from global growth in surgical procedures and multimodal analgesia guidelines, positioning it favorably in the analgesic market.

• Regulatory approval and clinician acceptance remain critical success factors; early engagement with health authorities and key opinion leaders are essential.

• High manufacturing and approval costs necessitate scalable production and strategic pricing to optimize profitability.

• expansion into emerging markets offers significant revenue opportunities but requires tailored regulatory and distribution strategies.

• Maintaining a focus on safety, efficacy, and cost-effectiveness will drive sustained adoption and financial gains.

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FAQs

1. What factors influence COMBOGESIC IV’s market adoption?
   Regulatory approval, clinical efficacy, safety profile, clinician familiarity, and reimbursement policies are key determinants.

2. How does COMBOGESIC IV compare to traditional opioid analgesics?
   It offers a multimodal mechanism with potentially fewer side effects and lower dependency risk, aligning with current opioid-sparing trends.

3. What are the main regulatory challenges for COMBOGESIC IV?
   Variability in approval processes across jurisdictions, requirements for extensive clinical trials, and safety monitoring.

4. What regional markets hold the most promise for COMBOGESIC IV’s growth?
   North America and Europe for mature markets; Asia-Pacific and Latin America for emerging opportunities.

5. What strategic actions can pharmaceutical companies take to maximize COMBOGESIC IV’s success?
   Focused clinical research, clinician education, formation of local partnerships, and adaptive pricing strategies.

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References

[1] Market Research Future. (2022). Intravenous Analgesics Market Analysis.
[2] Chou, R., et al. (2016). Management of Postoperative Pain: A Systematic Review. JAMA.
[3] GlobalData. (2022). Postoperative Pain Management Market Report.
[4] World Health Organization. (2021). Healthcare Infrastructure and Surgical Trends.