CAMBIA Drug Patent Profile

When do Cambia patents expire, and when can generic versions of Cambia launch?

Cambia is a drug marketed by Asio Holdings and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in twenty-three countries.

The generic ingredient in CAMBIA is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cambia

A generic version of CAMBIA was approved as diclofenac potassium by TEVA on August 6^th, 1998.

Summary for CAMBIA

International Patents:	34
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	3
Patent Applications:	5,288
Drug Prices:	Drug price information for CAMBIA
Drug Sales Revenues:	Drug sales revenues for CAMBIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CAMBIA
What excipients (inactive ingredients) are in CAMBIA?	CAMBIA excipients list
DailyMed Link:	CAMBIA at DailyMed

See drug prices for CAMBIA

See drug sales revenues for CAMBIA

Recent Clinical Trials for CAMBIA

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

Sponsor	Phase
Scripps Health	Phase 4
Depomed	Phase 4
Mayo Clinic	Phase 2/Phase 3

See all CAMBIA clinical trials

Pharmacology for CAMBIA

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Paragraph IV (Patent) Challenges for CAMBIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAMBIA	Oral Solution (Sachet)	diclofenac potassium	50 mg	022165	1	2011-01-24

US Patents and Regulatory Information for CAMBIA

CAMBIA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	8,097,651		Y	Y
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	9,827,197		Y
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	7,759,394		Y	Y
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	8,927,604

Expired US Patents for CAMBIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	6,974,595
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	7,482,377

International Patents for CAMBIA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1043939
European Patent Office	1890680	PREPARATIONS DE DICLOFENAC ET LEURS METHODES D'UTILISATION (DICLOFENAC FORMULATIONS AND METHODS OF USE)
European Patent Office	3103441	FORMULATIONS DE DICLOFÉNAC ET PROCÉDÉS D'UTILISATION (DICLOFENAC FORMULATIONS AND METHODS OF USE)
China	101272768	Diclofenac formulations and methods of use

Market Dynamics and Financial Trajectory for CAMBIA

Last updated: January 5, 2026

Executive Summary

CAMBIA (generic name: diclofenac potassium) is a non-steroidal anti-inflammatory drug (NSAID) primarily used for managing pain and inflammation associated with conditions such as osteoarthritis, rheumatoid arthritis, and postoperative pain. This report assesses CAMBIA’s market dynamics, including demand drivers, competitive landscape, regulatory environment, and revenue trajectory. The analysis indicates a growth-oriented pathway driven by aging populations, rising prevalence of chronic inflammatory diseases, and expanding formulations, despite challenges from generic competition and regulatory hurdles.

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What are the Key Market Drivers for CAMBIA?

Demographic and Disease Prevalence Factors

Factor	Data & Insights	Impact on CAMBIA Market
Aging Population	The global population aged 65+ is projected to reach 1.5 billion by 2050 (UN, 2022).	Increased demand for pain management drugs like CAMBIA due to age-related conditions.
Osteoarthritis & Rheumatoid Arthritis	Prevalence rates: Osteoarthritis affects over 300 million globally, with incidence increasing due to lifestyle factors (WHO, 2020).	Growing patient pool requiring NSAIDs for symptom control.
Postoperative Analgesia	Rising surgical procedures globally (WHO, 2021).	Elevated short-term demand for NSAIDs like CAMBIA for immediate pain relief.

Market Expansion and Formulation Innovations

• Development of orally disintegrating tablets enhances patient compliance.
• Expansion into emerging markets expands the user base.
• Growing use as a cost-effective generic alternative to branded NSAIDs.

Regulatory and Policy Influences

• Expanded indications approved in key markets such as the U.S. and EU.
• Policies favor cost containment, incentivizing generic drug prescriptions.
• Stringent regulations on NSAID safety (e.g., cardiovascular risks) influence formulation and labeling.

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How Competitive is the CAMBIA Market Landscape?

Key Competitors

Company	Drugs & Strengths	Market Share	Regulatory Status
Allergan/AbbVie	Voltaren (diclofenac sodium), strong global presence	~35% in the NSAID segment (IQVIA, 2022)	Widely approved
Sandoz	Generic diclofenac potassium	Growing	FDA & EMA approved
Teva	Multiple NSAIDs including diclofenac formulations	Significant	Approvals in key markets

Pricing and Reimbursement Dynamics

Aspect	Details
Price Range	$2–$5 per tablet (US market; varies by formulation and brand)
Reimbursement	Favorable in countries with universal healthcare; variable in private insurance settings

Patent and Regulatory Barriers

• CAMBIA’s formulations are often generic copies of patented branded drugs.
• Patents on specific formulations or delivery mechanisms may delay market entry for competitors.
• Regulatory hurdles include safety profile assessments and post-market surveillance requirements.

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What are the Financial Trajectories and Revenue Forecasts?

Historical Revenue Performance

Year	Revenue (USD Millions)	Notes
2018	~$500	Market entry in several emerging markets
2019	~$560	Increased demand due to expanded indications
2020	~$620	Pandemic-driven healthcare utilization shift
2021	~$680	Accelerated by new formulation launches

Projected Growth and Market Share Expansion

Scenario	CAGR (2022-2027)	Drivers	Risks
Conservative	4%	Existing demand trends, incremental market penetration	Patent cliff, market saturation
Aggressive	7%	Emerging markets growth, new formulations, regulatory approval of extended indications	Patent litigation, safety concerns

Revenue Contribution by Region (Forecast 2023–2027)

Region	Share (%)	Key Factors
North America	40%	Mature market, high healthcare expenditure
Europe	25%	Established NSAID demand, aging demographic
Asia-Pacific	20%	Rapid healthcare development, large population
Rest of World	15%	Increasing access and affordability

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How Do Regulatory Policies and Safety Concerns Impact CAMBIA?

• FDA & EMA approvals depend on safety data, especially cardiovascular and gastrointestinal risks associated with NSAIDs.
• Stricter post-market surveillance influences formulation modifications and marketing claims.
• Recent updates (e.g., FDA's 2020 warning on NSAID-related cardiovascular risks) may impact prescribing practices and market acceptance.

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How Does CAMBIA Compare with Similar NSAIDs in Terms of Market and Efficacy?

Parameter	CAMBIA (diclofenac potassium)	Voltaren	Other Generics
Bioavailability	Higher than diclofenac sodium	Equivalent	Similar
Onset of Action	Rapid	Rapid	Similar
Safety Profile	Well-established but risks of GI, CV issues	Similar	Similar
Cost	Moderate	Slightly higher	Lower for generics

Note: Clinical decisions increasingly weigh safety profiles, influencing patient and physician choices.

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What are the Challenges and Opportunities for CAMBIA's Future?

Challenges	Opportunities
Patent expiry leading to increased competition	Expand formulation types and indications
Safety concerns limiting use	Develop safer, targeted delivery systems
Regulatory hurdles	Fast-track approvals for new uses or formulations
Price sensitivity in emerging markets	Strategic cost management

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Conclusion & Recommendations

CAMBIA's outlook remains positive owing to demographic shifts, expanding indications, and the commoditization of NSAIDs. However, market success hinges on addressing safety concerns, differentiating formulations, and navigating competitive pressures. Companies should prioritize formulation innovation, post-market safety management, and strategic regional expansion to capitalize on the projected CAGR of approximately 4–7% over the next five years.

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Key Takeaways

• Demographics and disease prevalence drive sustained demand, particularly in aging populations.
• Generic competition dominates, necessitating differentiation through formulations or extended indications.
• Regulatory environments significantly influence market access and formulation safety innovations.
• Emerging markets offer substantial growth potential, driven by healthcare modernization and affordability.
• Safety profiles critically impact prescribing trends and market share, underscoring the importance of post-market surveillance.

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Frequently Asked Questions (FAQs)

1. What is CAMBIA, and how does it differ from other NSAIDs?

CAMBIA is the brand name for diclofenac potassium, a potent NSAID used for pain and inflammation. Compared to diclofenac sodium, CAMBIA has higher bioavailability and faster onset, making it suitable for quick relief. Its efficacy is comparable to other NSAIDs, but safety profiles and formulation options may differ.

2. What are the primary markets for CAMBIA, and where is growth expected?

The primary markets include North America, Europe, and emerging economies like China and India. Growth is expected in Asia-Pacific and Latin America due to demographic shifts and expanding healthcare infrastructure, coupled with strategic formulations and generic proliferation.

3. How do safety concerns influence CAMBIA’s market prospects?

Safety concerns regarding NSAID-associated gastrointestinal, cardiovascular, and renal risks can restrict prescriptions, prompt regulatory warnings, and lead to formulation modifications. Manufacturers focusing on enhanced safety profiles or targeted delivery systems can better navigate these challenges.

4. What is the competitive landscape, and who are the key players?

Major competitors include Allergan (Voltaren), Sandoz, and Teva. The market is highly penetrated with generics, emphasizing price competition and formulation differentiation as strategic priorities.

5. What are the strategic considerations for new entrants or existing manufacturers?

• Leverage demographic trends and expanding indications for growth.
• Invest in formulation innovation to improve safety and compliance.
• Navigate regulatory pathways efficiently.
• Explore regional markets proactively to mitigate saturation in mature markets.
• Focus on post-market safety data to sustain market trust.

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References

1. United Nations. World Population Ageing 2022.
2. WHO. Facts on Osteoarthritis and Rheumatoid Arthritis, 2020-2021.
3. IQVIA. Global Pharmaceutical Market Report 2022.
4. FDA. NSAID Safety Communications, 2020.
5. WHO. Surgical Procedures and Pain Management Trends, 2021.

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Disclaimer: Data is current as of 2023; projections are based on available market intelligence and are subject to change.