COMBOGESIC IV Drug Patent Profile

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

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 January 14, 2036. 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

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 11,213,498.

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

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
Canada	2955557
Slovenia	3169307
Mexico	2013005113	UNA COMPOSICION COMBINADA. (A COMBINATION COMPOSITION.)
San Marino	T201900481

COMBOGESIC IV: Investment Scenario and Fundamentals Analysis

Last updated: April 25, 2026

What is COMBOGESIC IV and what is its patent-facing profile?

COMBOGESIC IV is a brand name for an injectable analgesic/anti-inflammatory combination. In markets where COMBOGESIC is sold (notably India), the typical formulation for COMBOGESIC tablets and injectable variants is diclofenac potassium + paracetamol (acetaminophen). The label concept is consistent across the brand family, but COMBOGESIC IV (injectable) is marketed as an IV dosage form rather than an oral product.

Patent-facing profile (practical investment lens):

• Combination of established actives: Diclofenac and paracetamol are long-established molecules with extensive generic penetration globally. Investment outcomes typically hinge on formulation-specific IP (process, stability, solubilization, IV compatibility, dosing regimens) rather than on new molecular entities.
• Likely low probability of durable exclusivity from new-use or formulation-only IP: Unless the IV version introduces a defensible, data-backed formulation/process that can survive validity challenges, the product usually tracks the generic lifecycle of the individual actives and standard combinations.
• Regulatory and pricing pressure from generics: For established analgesic/NSAID combinations, commercialization tends to face rapid price erosion after first generic entries.

What is the fundamentals setup for an IV analgesic/NSAID combination?

Therapeutic value proposition

COMBOGESIC IV sits in a common hospital analgesia lane:

• Indication class: acute pain control and inflammatory pain management in clinical settings (post-procedural, musculoskeletal pain, and similar use cases).
• Mechanism coverage (expected):
  • Diclofenac: NSAID anti-inflammatory and analgesic effect
  • Paracetamol: central analgesic and antipyretic effect

Commercial fundamentals that drive returns

For an IV analgesic combination, the investment-grade drivers usually are:

• Hospital channel access (tender cycles, pharmacy inclusion, formulary placement)
• Supply reliability and unit-cost position (IV products are sensitive to procurement specs, pack size, and availability)
• Safety and handling profile (IV compatibility, precipitation risk, and stability drive procurement confidence)
• Competitive intensity (multiple brands and generics compete in the same analgesic/NSAID class)

Demand stability

Demand for analgesics used in hospitals tends to be:

• Recurring, tied to procedure volumes and admissions
• Price elastic with frequent substitution across equivalent analgesic classes
• Not typically linked to payer innovation curves, but to procurement economics

How does COMBOGESIC IV compare versus “durability” profiles in pharmaceuticals?

COMBOGESIC IV is best treated as a commercial execution and formulation defensibility story, not a “blockbuster exclusivity” story.

Durability ranking (relative)

Attribute	COMBOGESIC IV (expected)	Typical “durability” winner (NME/strong modality IP)
Core molecule novelty	Diclofenac/paracetamol are established	New molecular entity or platform with strong patent estate
Exclusivity source	Likely formulation/process and brand registration	Broad claims around composition, use, and manufacturing
Generic pressure	High after market entry	Lower if patent barriers persist
Forecast volatility	Medium to high (tender price swings)	Lower if exclusivity blocks competitors

What are the likely patent and exclusivity pathways investors should map?

Given the established actives, the most relevant IP axes for an IV combination product are:

1. Formulation patents
   • Solubilization and stabilization approach for IV diclofenac-containing compositions
   • Compatibility with excipients, pH control, and container-closure stability
2. Manufacturing/process patents
   • Mixing order, sterilization method, filtration approach, or scale-up controls that materially impact stability and impurity profiles
3. Regulatory exclusivity
   • Data exclusivity or market exclusivity depends on jurisdiction and filing strategy; for older actives this often offers limited incremental protection
4. Trademarks and brand controls
   • In practice, brand differentiation helps but does not block generics with AB-equivalent formulations

What does the investment scenario look like in a generic-heavy IV analgesic segment?

Scenario 1: Base case (generic encroachment, brand survives via channel)

• Expected market outcome: price compression over time as generics enter
• Where value can persist: hospitals continue ordering the product if it meets tender criteria on price, availability, and perceived reliability
• Return drivers: margins depend on manufacturing cost advantage and procurement positioning

Scenario 2: Upside case (strong formulation/process IP or preferential tender access)

• Required conditions:
  • Formulation/process claims that survive challenges
  • Tender specifications that favor a particular stability profile, pack format, or impurity profile
• Return drivers: slower generic substitution and better hospital stickiness

Scenario 3: Downside case (AB-equivalence and rapid substitution)

• Expected market outcome: accelerated erosion of branded share and margin
• Return drivers shift to: supply scale, cost-down, and portfolio resilience (other SKUs and line extensions)

What are the key commercial KPIs to underwrite for COMBOGESIC IV?

For investment underwriting, the material KPIs tend to be operational and procurement-driven:

• Tender participation rate and win rate by geography
• Net price realization vs list price (discounting and tender pricing)
• Gross margin trend (product-level manufacturing and logistics costs)
• Loss rate to AB-equivalent competitors
• Inventory turn and stockout rate (IV lines are reputationally sensitive)
• Pharmacovigilance signal rate (serious adverse event frequency per cohort, where trackable)

What are the foundational risk points investors should price?

Regulatory and safety risk

• NSAIDs carry known class risks (gastrointestinal, renal, cardiovascular in susceptible populations). Even with paracetamol addition, hospital protocols and contraindication management matter.

Competitive and pricing risk

• In analgesics, price-based switching is common. IV procurement is heavily tender-driven.

Manufacturing risk

• IV stability, precipitation control, and impurity limits are essential for acceptance. Any quality variation increases rejection risk.

How should investors frame valuation and funding decisions for COMBOGESIC IV?

Because durability is likely limited, investors should treat valuations as cash-flow multiple trades on execution rather than as long-dated growth claims.

Practical valuation approach for this category:

• Value the product on normalized hospital demand and expected margin after generic entries
• Discount aggressively for tender-driven price decay
• Weight outcomes toward companies with lower COGS and reliable supply

Capital allocation implication:

• If the company holds defensible formulation IP, it supports premium margin sustainability.
• If IP is thin, investment should focus on cost-down, distribution strength, and manufacturing quality metrics.

What is the investment checklist tied to COMBOGESIC IV’s fundamentals?

IP checklist (what matters if it exists)

• Composition-of-matter or close formulation claims that cover the IV-specific composition
• Process claims tied to stability-improving manufacturing controls
• Evidence of non-obviousness based on comparative stability, impurity control, or solubility outcomes

Commercial checklist

• Track record of hospital tender wins
• Supply capacity for IV manufacturing and packaging
• Documented quality system performance (deviations, batch failures, recalls)

Financial checklist

• Gross margin structure by site
• Working capital needs (IV inventory cycle)
• Unit economics by geography

Key Takeaways

• COMBOGESIC IV is an IV analgesic/anti-inflammatory combination that is structurally exposed to generic competition because it uses long-established active ingredients (diclofenac and paracetamol in the brand family).
• The investment case depends primarily on formulation/process defensibility and hospital channel execution, not on broad, long-lived molecular exclusivity.
• Underwriting should be margin-and-tender-driven, with pricing decay and substitution risk baked into forecasts.
• The highest-leverage diligence targets are stability/compatibility differentiation, tender performance, and batch quality reliability.

FAQs

1. Is COMBOGESIC IV an NME that should be valued like a new molecular entity?
No. It should be valued as an established-active IV product where returns depend on formulation/process and commercial execution.

2. What is the biggest threat to branded share for COMBOGESIC IV in most markets?
AB-equivalent generic substitution and tender price pressure.

3. What types of IP would matter most for an IV combination like COMBOGESIC IV?
IV-specific formulation and manufacturing/process claims that improve stability, solubility, impurity control, or dosing usability.

4. What KPIs best predict long-run profitability for IV analgesic brands?
Net tender price realization, gross margin trend, tender win rate, and supply reliability.

5. How should investors model demand for an IV analgesic combination?
Use procedure/admission-driven hospital demand with strong assumptions on price decay and substitution timing after generic entry.

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References

[1] European Medicines Agency (EMA). Diclofenac: assessment and pharmacovigilance information. EMA. https://www.ema.europa.eu/
[2] U.S. FDA. Acetaminophen (paracetamol) safety communications and labeling references. FDA. https://www.fda.gov/
[3] World Health Organization (WHO). Analgesics and NSAIDs class information and safety considerations. WHO. https://www.who.int/