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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 five patents protecting this drug.

This drug has sixty-five patent family members in thirty 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:	65
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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.

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 eight 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	12,083,087
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,213,498		Y
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	11,446,266
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

International Patents for COMBOGESIC IV

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

Country	Patent Number	Title	Estimated Expiration
China	106794163	包含对乙酰氨基酚和布洛芬的水性制剂 (Aqueous formulation comprising paracetamol and ibuprofen)
Hungary	E045442
Japan	2017522382	パラセタモール及びイブプロフェンを含む水性配合物
World Intellectual Property Organization (WIPO)	2016009067
Eurasian Patent Organization	201790223	ВОДНЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ ПАРАЦЕТАМОЛ И ИБУПРОФЕН
Slovenia	3169307
Mexico	2017000764	FORMULACION ACUOSA QUE COMPRENDE PARACETAMOL E IBUPROFENO. (AQUEOUS FORMULATION COMPRISING PARACETAMOL AND IBUPROFEN.)

COMBOGESIC IV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COMBOGESIC® IV

Introduction

The launch of COMBOGESIC® IV by Hikma Pharmaceuticals marks a significant milestone in the pain management sector, particularly in the context of the ongoing opioid crisis. This article delves into the market dynamics and financial trajectory of COMBOGESIC® IV, highlighting its potential impact on the pharmaceutical industry and healthcare policies.

Market Need and Demand

The pharmaceutical industry is under increasing pressure to develop alternatives to opioid analgesics due to the rising concerns over opioid dependency and its associated societal costs. COMBOGESIC® IV, a non-opioid, multimodal analgesic combining acetaminophen and ibuprofen, aligns perfectly with current medical recommendations and market demand for safer pain management options[4].

Clinical Efficacy

In a Phase 3 clinical trial, COMBOGESIC® IV demonstrated superior efficacy compared to acetaminophen IV and ibuprofen IV used alone. The product provided more than double the pain relief and achieved meaningful pain relief faster than the individual components or placebo groups. This superior analgesia efficacy positions COMBOGESIC® IV as a compelling alternative in pain management[2][4][5].

Market Acceptance and Adoption

The FDA approval of COMBOGESIC® IV in the US is a critical step in its market acceptance. Given its positive clinical trial results and the endorsement of multimodal pain management approaches by the American Society of Anesthesiology, healthcare providers are likely to adopt COMBOGESIC® IV as a preferred treatment option. This could lead to a significant shift in prescribing practices, favoring opioid-sparing strategies[4].

Global Presence and Market Expansion

COMBOGESIC® IV is already licensed in over 100 countries and marketed in more than 20, indicating a well-established international presence. This global footprint can be leveraged to accelerate market penetration and adoption in the US through strategic partnerships and existing distribution networks[4].

Competitive Advantage

The exclusive license and distribution agreement with AFT Pharmaceuticals for the US market provides Hikma with a competitive edge in the pain management sector. The product's dual mechanism of action and superior efficacy compared to individual analgesics make it a unique offering in a market dominated by single-agent therapies[4].

Financial Implications

The launch of COMBOGESIC® IV is expected to have a positive impact on Hikma's financial performance. Given the strong market demand for alternative pain management therapies, COMBOGESIC® IV could capture a significant share of this market. Investors are likely to monitor the adoption rates and revenue streams closely, as the product's performance in Phase 3 clinical trials suggests robust sales potential[4].

Revenue Growth

Hikma's overall revenue has shown strong growth, with a 10% increase in the first half of 2024 compared to the previous year. The Injectables segment, which includes COMBOGESIC® IV, saw a 4% revenue growth, reflecting good performance in North America and the MENA region. This trend is expected to continue with the launch of COMBOGESIC® IV, contributing to Hikma's revenue growth[3].

Market Share and Expansion

North America, a dominant region for intravenous ibuprofen and other pain management drugs, is anticipated to be a key market for COMBOGESIC® IV. Hikma's strong presence in this region, coupled with the product's superior efficacy, positions it well to capture a significant market share. The Asia Pacific region, with its burgeoning healthcare industries and large patient pools, also presents immense opportunities for market expansion through strategic partnerships[1].

Regulatory and Policy Impact

The FDA approval of COMBOGESIC® IV aligns with public health initiatives aimed at combating the opioid crisis. This endorsement could set a precedent for future pain management strategies, influencing healthcare policy and prescribing practices. The societal impact of reducing opioid prescriptions could be significant, potentially leading to lower rates of addiction and overdose, and alleviating the economic burden on healthcare systems[4].

Challenges and Risks

While the launch of COMBOGESIC® IV is promising, there are risks and challenges to consider. These include potential competition from other pain management therapies, regulatory changes, and shifts in healthcare policies. Additionally, the long-term financial health of Hikma and the sustainability of its growth will depend on its ability to innovate and diversify its product portfolio[4].

Key Takeaways

• Superior Efficacy: COMBOGESIC® IV provides more than double the pain relief compared to acetaminophen IV and ibuprofen IV alone.
• Market Demand: Aligns with the growing need for non-opioid pain management options.
• Global Presence: Licensed in over 100 countries and marketed in more than 20.
• Financial Potential: Expected to contribute significantly to Hikma's revenue growth.
• Regulatory Impact: Aligns with public health initiatives to reduce opioid dependency.

FAQs

What is COMBOGESIC® IV?

COMBOGESIC® IV is a non-opioid, multimodal analgesic combining acetaminophen and ibuprofen, designed for adult pain management.

How does COMBOGESIC® IV compare to other pain management options?

In clinical trials, COMBOGESIC® IV provided more than double the pain relief compared to acetaminophen IV and ibuprofen IV used alone, with a shorter time to meaningful pain relief.

What is the market potential for COMBOGESIC® IV?

Given its superior efficacy and alignment with current medical recommendations, COMBOGESIC® IV is expected to capture a significant share of the pain management market, particularly in regions like North America and the Asia Pacific.

How does the launch of COMBOGESIC® IV impact Hikma's financial performance?

The launch is expected to contribute to Hikma's revenue growth, with the product's strong performance in clinical trials suggesting robust sales potential.

What are the regulatory implications of COMBOGESIC® IV?

The FDA approval of COMBOGESIC® IV aligns with public health initiatives to reduce opioid dependency and could influence healthcare policy and prescribing practices.

Sources

1. Coherent Market Insights: Intravenous (IV) Ibuprofen Market Size & Share Analysis.
2. Hikma: Hikma announces US launch of COMBOGESIC® IV.
3. Hikma: Hikma delivers strong H1 performance and upgrades Group guidance.
4. Stock Titan: Hikma announces US launch of COMBOGESIC® IV.
5. PR Newswire: Hikma announces US launch of COMBOGESIC® IV.