CAMBIA Drug Patent Profile

Which patents cover Cambia, and what generic alternatives are available?

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-nine 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
Canada	2254144	COMPOSITION PHARMACEUTIQUE A BASE DE DICLOFENAC (PHARMACEUTICAL COMPOSITIONS BASED ON DICLOFENAC)
China	112755014	双氯芬酸制剂和使用方法 (DICLOFENAC FORMULATIONS AND METHODS OF USE)
Poland	188883
South Africa	200710858	Diclofenac formulations and methods of use
European Patent Office	0906092	COMPOSITION PHARMACEUTIQUE A BASE DE DICLOFENAC (PHARMACEUTICAL COMPOSITIONS BASED ON DICLOFENAC)

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: CAMBIA

Introduction
CAMBIA (NSAID, diclofenac potassium) is a nonsteroidal anti-inflammatory drug (NSAID) primarily indicated for the management of acute pain, particularly in postoperative settings. Since its approval in the early 2000s, CAMBIA has gained prominence as an alternative to other NSAIDs due to its fast onset of action and targeted delivery system. Analyzing its market dynamics and financial trajectory involves examining factors such as regulatory status, competitive landscape, patent life, pricing strategies, and emerging market opportunities.

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Regulatory Landscape and Clinical Adoption
CAMBIA received FDA approval in 2002, marketed by Valeant Pharmaceuticals (later acquired by Bausch Health), which positioned it prominently within the acute pain management segment. The drug’s unique delivery system—powder for oral suspension—differentiates it from traditional NSAIDs, appealing to both clinicians and patients seeking rapid relief with a favorable side effect profile. Regulatory-backed endorsements and detailed clinical trial data facilitated its adoption in hospitals and surgical centers [1]. Ongoing regulatory reviews in emerging markets, such as Asia-Pacific and Latin America, are anticipated to expand its geographic uptake, aligning with a broader trend of specialty NSAID prescribing.

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Market Dynamics: Competitive Forces and Market Share
The NSAID segment faces intense competition from traditional oral formulations (ibuprofen, naproxen), topical NSAIDs, and novel delivery platforms such as patches and injectables. CAMBIA’s niche lies within the acute pain indication, especially post-surgical pain, where rapid onset is prioritized. However, its market share has been constrained by several factors:

• Generic Competition: Patent expiry for the original formulation has introduced biosimilar and generic diclofenac options, exerting downward pressure on prices. The patent landscape, including composition-of-matter and delivery patents, significantly influences entry of generics.
• Pricing and Reimbursement: As a specialty formulation, CAMBIA commands premium pricing, but reimbursement constraints and formulary decisions can hinder wider adoption. Payers increasingly favor cost-effective generics, impacting branded sales [2].
• Physician and Patient Awareness: Adoption depends on clinician familiarity with the product, perceptions of efficacy, and ease of administration. Educational initiatives and clinical guidelines influence prescribing patterns.

Emerging competitors in the fast-acting NSAID niche are investing in novel formulations and delivery technologies, further intensifying competition. Nonetheless, CAMBIA maintains a dedicated segment in acute pain management, especially in surgical settings where rapid relief and safety profiles are critical.

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Patent and Intellectual Property Trajectory
The initial patent protections for CAMBIA’s formulation provided exclusivity through roughly 2015–2020. Post-expiry, the market experienced increased generic entry, which significantly impacted sales revenue. However, Bausch Health has pursued secondary patents related to manufacturing processes, delivery devices, and specific formulations to extend market exclusivity where possible [3].

These patent strategies aim to delay commoditization, sustain higher pricing, and provide room for lifecycle management. Nonetheless, patent cliffs are inevitable, requiring the company to innovate continually—such as developing fixed-dose combinations or targeted delivery systems—to preserve market position.

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Pricing Dynamics and Revenue Streams
CAMBIA’s premium pricing strategy capitalizes on its differentiated delivery system. Data indicates that healthcare providers and patients are willing to pay a premium for rapid-onset NSAID options aligned with postoperative pain protocols [4]. However, reimbursement policies and generic competition exert downward pressure on pricing, especially in regions with aggressive price control measures.

Revenue growth hinges on increasing penetration in existing markets—hospitals, surgical centers, emergency departments—and expanding into new geographic territories. The company's strategic focus on clinical education and clinical pathway integration aims to bolster uptake and maximize pricing benefits.

Manufacturing costs for specialized formulations are relatively stable, but they could be impacted by supply chain disruptions or the implementation of novel delivery devices. The financial trajectory, therefore, depends heavily on market penetration, patent protection, and competitive pricing strategies.

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Emerging Market Opportunities and Future Outlook
The global pain management market continues to expand, driven by aging populations, increased surgical procedures, and rising prevalence of chronic inflammatory conditions. For CAMBIA, key opportunities include:

• Growth in Emerging Markets: Countries such as China, India, and Brazil are increasing healthcare expenditure and expanding access to innovative pain therapies. Regulatory approvals and market entry strategies are pivotal for capturing this growth potential.
• Postoperative and Emergency Care Settings: Adoption in outpatient surgeries and emergency departments offers high-volume, high-acuity prescribing opportunities. Demonstrating cost-effectiveness and clinical benefits remains critical.
• Pipeline Innovations: Investment in extended-release formulations, combination therapies, or novel delivery systems could rejuvenate sales and extend patent life.

Overall, the financial outlook for CAMBIA hinges on the effective balancing of patent management, competitive positioning, and geographic expansion strategies. The rising demand for rapid-acting analgesics positions CAMBIA well if commercialization pathways are executed efficiently.

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Regulatory and Market Risks
Several risks threaten the financial trajectory of CAMBIA:

• Generic Competition: Loss of patent exclusivity can lead to significant revenue erosion unless offset by new formulations or indications.
• Pricing Pressures: Governments and insurers worldwide are increasingly demanding price concessions, which could erode margins.
• Safety and Efficacy Concerns: Adverse events or new safety data could impact clinical adoption and reimbursement policies.
• Market Access Delays: Regulatory hurdles or reimbursement rejections in emerging markets could slow expansion.

Mitigation strategies include innovation, geographic diversification, and strategic partnerships with healthcare providers.

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Key Takeaways

• CAMBIA’s differentiated fast-onset NSAID positioning supports strong niche performance in postoperative pain management despite competitive pressures.
• Patent expiries have led to increased generic competition, challenging revenue growth prospects; secondary patent strategies are essential for extension.
• Reimbursement landscape and pricing strategies are critical determinants of financial success, especially in cost-sensitive markets.
• Expansion into emerging markets, coupled with pipeline innovations, offers significant upside to the drug’s financial trajectory.
• Risks include patent cliffs, pricing pressures, and safety concerns; proactive lifecycle management is vital for sustained profitability.

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FAQs

1. What factors contribute to CAMBIA’s competitive advantage in the NSAID market?
CAMBIA's rapid onset of action, targeted delivery system, and clinical utility in postoperative pain provide a distinctive advantage over traditional NSAIDs, particularly in hospital settings requiring quick relief.

2. How does patent expiry impact CAMBIA’s market share?
Patent expiry opens the market to generics, reducing branded sales and challenging profitability unless the company introduces new formulations or extends exclusivity through secondary patents.

3. What are the key growth opportunities for CAMBIA in emerging markets?
Emerging markets' expanding healthcare infrastructure, increasing surgical procedures, and regulatory approvals offer opportunities to capture new patient populations and revenue streams.

4. How do pricing strategies influence CAMBIA’s financial trajectory?
Premium pricing sustains high margins in branded segments, but reimbursement policies and market competition necessitate balancing price strategies to maintain market share and profitability.

5. What is the outlook for CAMBIA’s pipeline and lifecycle management?
Continued innovation through extended-release formulations, combination therapies, and novel delivery methods is crucial to extending the product’s lifecycle and enhancing financial performance.

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References
[1] FDA Approval Documents for Cambia (Diclofenac Potassium), 2002.
[2] MarketResearch.com, “NSAID Market Trends and Pricing Strategies,” 2021.
[3] Patent filings and intellectual property reports published by Valeant/Bausch Health.
[4] IQVIA sales data and healthcare provider surveys on NSAID prescribing patterns, 2022.