COMBOGESIC Drug Patent Profile

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

Combogesic is a drug marketed by Aft Pharms Us and Hikma and is included in two NDAs. There are nine patents protecting this drug.

This drug has fifty-six patent family members in thirty-four countries.

The generic ingredient in COMBOGESIC 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

Indicators of Generic Entry

Summary for COMBOGESIC

International Patents:	56
US Patents:	3
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
What excipients (inactive ingredients) are in COMBOGESIC?	COMBOGESIC excipients list
DailyMed Link:	COMBOGESIC at DailyMed

Recent Clinical Trials for COMBOGESIC

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

Sponsor	Phase
AFT Pharmaceuticals, Ltd.	PHASE3

See all COMBOGESIC clinical trials

Pharmacology for COMBOGESIC

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

US Patents and Regulatory Information for COMBOGESIC

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes	11,534,407		Y
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	12,083,087
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,389,416		Y
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes	11,197,830		Y

Expired US Patents for COMBOGESIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023	10,532,036

International Patents for COMBOGESIC

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

Country	Patent Number	Title	Estimated Expiration
Canada	2570474	COMPOSITION COMBINEE (A COMBINATION COMPOSITION)
Mexico	2007000117	UNA COMPOSICION DE COMBINACION. (A COMBINATION COMPOSITION.)
Eurasian Patent Organization	202192118
Canada	3131917
Israel	285866

Supplementary Protection Certificates for COMBOGESIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: COMBOGESIC

Last updated: July 27, 2025

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Introduction

COMBOGESIC, a fixed-dose combination medication, represents a strategic formulation designed to enhance pain management efficacy through synergistic pharmacological agents. Its development and commercialization are influenced by complex market dynamics spanning regulatory, competitive, and demographic factors. This analysis explores the evolving landscape, pharmaceutical positioning, and financial trajectory of COMBOGESIC within the global analgesics market.

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Pharmacological Profile and Therapeutic Positioning

COMBOGESIC combines multiple active ingredients, typically an opioid analgesic with a non-opioid agent such as acetaminophen or NSAIDs, aimed at providing superior pain relief with minimized side effects. Its formulation addresses growing clinical demands for multimodal pain management, especially in chronic and post-operative pain contexts.

The combination's success hinges on demonstrating improved efficacy, safety, and patient compliance over monotherapies. Regulatory authorities, including the FDA and EMA, increasingly favor combination therapies that demonstrate clear therapeutic advantages, which influences the drug's market potential.

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Market Dynamics

Global Pain Management Market Trends

The global pain management market is projected to reach approximately USD 77.3 billion by 2027, with a compounded annual growth rate (CAGR) of around 6.8% (Fortune Business Insights, 2022). Growth drivers encompass aging populations, rising prevalence of chronic diseases such as arthritis and cancer, and an increasing emphasis on multimodal analgesia to address opioid dependence concerns.

Regulatory and Medical Acceptance

Regulatory agencies continue to scrutinize opioid-containing drugs amidst concerns over misuse and addiction. COMBOGESIC’s market success depends on navigating these regulatory landscapes by demonstrating safety protocols and abuse-deterrent formulations. Additionally, clinical evidence supporting improved patient outcomes bolsters its acceptance among physicians and payers.

Competitive Landscape

COMBOGESIC operates within a crowded analgesic segment. Major competitors include:

• Traditional analgesic monotherapies (e.g., paracetamol, NSAIDs)
• Other combination formulations (e.g., tramadol/paracetamol)
• Emerging modalities such as nerve blocks and implantable pain management devices

Market differentiation hinges on efficacy, safety profiles, dosing convenience, and formulary positioning.

Patents and Intellectual Property

Strong patent protection is crucial to secure market exclusivity. Patent expirations can lead to generic entry, significantly impacting revenue streams. Current IP strategies focus on formulation patents, new delivery mechanisms, and combination indications.

Pricing and Reimbursement Dynamics

Pricing strategies vary across regions, with developed markets demanding high-value propositions justified through cost-effectiveness analyses. Reimbursement pathways rely on demonstrating improvements in healthcare utilization, reduced hospitalizations, and enhanced patient adherence.

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Financial Trajectory

Research and Development Investment

The development pipeline for combination analgesics involves substantial R&D expenditure, particularly in clinical trials to establish safety and efficacy. Early-stage investments inform regulatory submissions, with costs varying based on regional requirements and trial complexity.

Market Entry and Launch Strategies

Initial market penetration is driven by key opinion leader advocacy, clinical guidelines adoption, and inclusion in formularies. Early adopters in hospital and outpatient settings facilitate broader acceptance.

Revenue Projections

Assuming successful regulatory approval in major markets such as the US, Europe, and Japan, COMBOGESIC could achieve:

• Year 1-2: Limited revenue, primarily from early adopters
• Years 3-5: Accelerated growth driven by expanded indications and formulary inclusion
• Long-term: Potential plateau or decline post-patent expiry unless follow-on formulations or new indications emerge

Based on comparable combination analgesics, annual revenues could reach USD 500 million to USD 1 billion within 5 years post-launch, contingent upon market uptake, pricing strategies, and competitive pressures.

Cost Considerations

Manufacturing costs benefit from economies of scale but may be higher initially due to complex formulation processes. Marketing and sales expenses are significant, aiming to educate prescribers on clinical advantages and establish presence in hospital formularies.

Profitability Outlook

Profit margins are influenced by market penetration, payer negotiations, and production costs. Effective patent protection and favorable reimbursement policies enhance profitability. Conversely, generic competition post-patent expiry could erode margins unless brand loyalty and differentiated value persist.

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Emerging Trends Impacting COMBOGESIC

• Shift Toward Non-Opioid Analgesics: Growing opioid skepticism favors non-opioid combinations, which could limit or reshape COMBOGESIC’s positioning.
• Personalized Pain Management: Advances in pharmacogenomics enable tailored therapies, potentially requiring formulation adjustments.
• Digital Health Integration: Use of digital adherence and monitoring tools could enhance treatment outcomes and data collection, positively impacting financial forecasts.
• Regulatory Environment: Increasing emphasis on abuse-deterrent formulations may necessitate formulation innovation, impacting development costs but offering premium market segments.

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Strategic Considerations

• Differentiation: Emphasizing unique formulation benefits, safety profiles, and clinical evidence.
• Market Expansion: Targeting emerging markets with growing pain management needs.
• Partnerships: Collaborations with healthcare providers and payers can facilitate faster adoption.
• Lifecycle Management: Developing new delivery systems, repurposing for other pain indications, or creating abuse-deterrent versions can prolong market exclusivity and revenue streams.

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Key Takeaways

1. Market potential for COMBOGESIC is significant, driven by the global demand for effective multimodal pain therapies amid regulatory scrutiny of opioids.
2. Regulatory success hinges on demonstrating safety, efficacy, and abuse mitigation; patent strength remains vital for protecting market share.
3. Financial trajectories forecast robust revenue growth within the first five years post-launch, with long-term stability dependent on lifecycle management strategies.
4. Competitive differentiation involves clinical data that establishes superiority over monotherapies and other combination products.
5. Emerging trends such as personalized medicine and digital health will shape product development and commercialization strategies.

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FAQs

1. What factors influence the regulatory approval of COMBOGESIC globally?
Approval depends on demonstrating safety, efficacy, and benefit over existing therapies, along with adherence to regional regulations, including abuse-deterrent capabilities and manufacturing standards.

2. How does patent protection impact COMBOGESIC’s market exclusivity?
Strong patents prevent generic competition, allowing premium pricing and market control until expiration, after which rapid generic entry can significantly reduce revenues.

3. What are the main challenges to COMBOGESIC’s commercialization?
Key challenges include opioid regulatory scrutiny, physician acceptance, competing therapies, pricing pressures, and patent expirations.

4. How can COMBOGESIC leverage emerging market opportunities?
Strategies include local partnerships, pricing adaptations, addressing regional unmet needs, and tailoring clinical evidence to local guidelines.

5. What are the prospects for lifecycle extension of COMBOGESIC?
Development of abuse-deterrent formulations, new delivery systems, additional indications, or combination variants can extend product lifecycle and revenue potential.

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References

[1] Fortune Business Insights. (2022). Pain Management Market Size, Share & Industry Analysis.
[2] U.S. Food and Drug Administration (FDA). Regulatory guidelines for combination analgesic drugs.
[3] MarketsandMarkets. (2023). Pain Management Market Trends and Forecasts.
[4] IQVIA. (2022). Global Pharmaceutical Market Insights.
[5] WHO. (2021). Global Strategy for Pain Management and Opioid Regulation.