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 eight patents protecting this drug.

This drug has fifty-one patent family members in thirty-three 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:	51
US Patents:	3
Applicants:	2
NDAs:	2
What excipients (inactive ingredients) are in COMBOGESIC?	COMBOGESIC excipients list
DailyMed Link:	COMBOGESIC at DailyMed

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			Y
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes
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			Y
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes			Y
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes

International Patents for COMBOGESIC

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	0700027
Spain	2381794
Australia	2008202029	A Combinatin Composition
South Korea	101370712
Colombia	2021011525	Composición farmacéutica que contiene acetaminofeno e ibuprofeno
Russian Federation	2007101686	КОМБИНИРОВАННАЯ КОМПОЗИЦИЯ

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

COMBOGESIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COMBOGESIC IV

Introduction

COMBOGESIC IV, a groundbreaking intravenous pain relief medication, has recently entered the U.S. market, offering a significant alternative to traditional opioid-based pain management. This article delves into the market dynamics and financial trajectory of COMBOGESIC IV, highlighting its potential impact on the pharmaceutical industry.

Market Overview of Intravenous Pain Relief

The global intravenous (IV) ibuprofen market, within which COMBOGESIC IV operates, is experiencing robust growth. Estimated to be valued at USD 6.91 billion in 2024, this market is projected to reach USD 11.13 billion by 2031, growing at a CAGR of 7%[4].

Product Profile: COMBOGESIC IV

COMBOGESIC IV is an intravenous formulation combining 1,000 mg of acetaminophen and 300 mg of ibuprofen. Developed by AFT Pharmaceuticals and launched in the U.S. by Hikma Pharmaceuticals in February 2024, this medication is approved by the FDA for mild to moderate pain relief and as an adjunct for severe pain alongside opioids[1][3].

Clinical Efficacy

In a Phase 3 clinical trial, COMBOGESIC IV demonstrated superior analgesia efficacy compared to acetaminophen IV and ibuprofen IV alone. It provided more than double the pain relief and achieved meaningful pain relief faster than the other treatments[3].

Market Drivers

Several factors are driving the adoption of COMBOGESIC IV:

Rising Prevalence of Pain Disorders

The increasing prevalence of pain disorders and the growing demand for effective analgesics are key drivers. Intravenous ibuprofen, including COMBOGESIC IV, is increasingly preferred for treating mild to moderate pain associated with medical or surgical conditions[4].

Multimodal Pain Management

The American Society of Anesthesiology's multimodal pain management strategy, which advocates for the use of multiple pain relief agents to achieve quicker and sustained relief, aligns well with the dual-action approach of COMBOGESIC IV[1].

Regulatory Support

Supportive regulatory guidelines for pain management have facilitated the approval and adoption of COMBOGESIC IV. The FDA approval in October 2023 marked a significant milestone in providing hospitals and healthcare providers with an alternative treatment option[1][3].

Financial Performance of Key Players

Hikma Pharmaceuticals

Hikma Pharmaceuticals, the U.S. licensee of COMBOGESIC IV, has reported strong financial performance. In the first half of 2024, Hikma saw a 10% increase in group revenue, with the Branded segment contributing significantly. The launch of COMBOGESIC IV is expected to further bolster their revenue, especially in the Injectables segment, which grew 4% in the first half of 2024[2].

AFT Pharmaceuticals

AFT Pharmaceuticals, the developer of COMBOGESIC IV, reported a 25% increase in full-year operating revenue to $195.4 million, driven by 20% growth in product sales and royalties. The launch of COMBOGESIC IV in the U.S. contributed significantly to this growth, with a milestone payment of circa $6 million from Hikma Pharmaceuticals[5].

Regional Market Dynamics

North America, particularly the U.S., is a dominant region for the intravenous ibuprofen market, including COMBOGESIC IV. This region is anticipated to hold 34.8% of the market share in 2024, driven by the strong presence of leading pharmaceutical companies and supportive regulatory guidelines[4].

Competitive Landscape

The market for intravenous pain relief medications is competitive, with several players such as Cumberland Pharmaceuticals, Cadila Healthcare, and XGEN PHARMACEUTICALS DJB, Inc. However, the unique dual-action formulation of COMBOGESIC IV sets it apart, offering a compelling alternative to single-agent treatments[4].

Challenges and Opportunities

Pricing Pressures

Despite the positive market dynamics, pricing pressures from payers are a significant challenge. Pharmaceutical companies are focusing on specialty and value-added products to mitigate these pressures[4].

Ongoing Research and Expansion

Ongoing research activities aimed at expanding the approved indications for intravenous ibuprofen, including COMBOGESIC IV, present new avenues for growth. This could further enhance the market position of COMBOGESIC IV in the coming years[4].

Financial Projections

Revenue Growth

Given the strong market acceptance and clinical efficacy, COMBOGESIC IV is expected to contribute significantly to the revenue growth of both Hikma Pharmaceuticals and AFT Pharmaceuticals. Hikma has upgraded its Group revenue and profit guidance for 2024, reflecting the positive impact of new product launches, including COMBOGESIC IV[2].

Profit Margins

While the launch of COMBOGESIC IV has been successful, there are short-term challenges such as overstocking and price discounting in certain regions. However, these are expected to be temporary, and the overall profit margins are anticipated to remain robust as the product gains more market traction[5].

Key Takeaways

• Market Growth: The intravenous ibuprofen market, including COMBOGESIC IV, is expected to grow at a CAGR of 7% from 2024 to 2031.
• Clinical Efficacy: COMBOGESIC IV has demonstrated superior pain relief compared to single-agent treatments.
• Regulatory Support: FDA approval and alignment with multimodal pain management strategies support its adoption.
• Financial Performance: Strong revenue growth is anticipated for both Hikma Pharmaceuticals and AFT Pharmaceuticals.
• Regional Dominance: North America is a key market, driven by strong pharmaceutical companies and supportive regulations.

FAQs

1. What is COMBOGESIC IV? COMBOGESIC IV is an intravenous pain relief medication combining 1,000 mg of acetaminophen and 300 mg of ibuprofen, approved for mild to moderate pain relief and as an adjunct for severe pain alongside opioids.

2. Who developed and launched COMBOGESIC IV? COMBOGESIC IV was developed by AFT Pharmaceuticals and launched in the U.S. by Hikma Pharmaceuticals in February 2024.

3. What are the key drivers of the intravenous ibuprofen market? The rising prevalence of pain disorders, increasing demand for analgesics, and supportive regulatory guidelines are key drivers of the intravenous ibuprofen market.

4. How does COMBOGESIC IV compare to other pain relief medications? COMBOGESIC IV has demonstrated more than double the pain relief of acetaminophen IV and ibuprofen IV alone in clinical trials, with a shorter time to meaningful pain relief.

5. What are the financial projections for COMBOGESIC IV? COMBOGESIC IV is expected to contribute significantly to the revenue growth of Hikma Pharmaceuticals and AFT Pharmaceuticals, with strong profit margins anticipated despite short-term challenges.

Sources

1. Grand View Research - Non-steroidal Anti-inflammatory Drugs Market Report, 2030
2. Hikma Pharmaceuticals - 2024 Interim Press Release
3. Hikma Pharmaceuticals - US Launch of COMBOGESIC® IV
4. Coherent Market Insights - Intravenous (IV) Ibuprofen Market Size & Share Analysis
5. AFT Pharmaceuticals - Full-Year Operating Revenue and Earnings Report 2024