CAMBIA Drug Patent Profile

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

Cambia is a drug marketed by Assertio Speclty 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-eight 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
Assertio Speclty	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	8,097,651		Y	Y
Assertio Speclty	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	9,827,197		Y
Assertio Speclty	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes	7,759,394		Y	Y
Assertio Speclty	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
Assertio Speclty	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	6,974,595
Assertio Speclty	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
Denmark	0906092
Croatia	P970269
Spain	2641889
Italy	1283029	COMPOSIZIONI FARMACEUTICHE A BASE DI DICLOFENAC
Canada	2632375	PREPARATIONS DE DICLOFENAC ET LEURS METHODES D'UTILISATION (DICLOFENAC FORMULATIONS AND METHODS OF USE)

Market dynamics and financial trajectory for CAMBIA

Last updated: April 26, 2026

What is CAMBIA in product and corporate terms?

CAMBIA is a brand of diclofenac potassium for acute pain, marketed by Cambia Pharmaceuticals, LLC. The brand’s market performance is driven by three forces: (1) diclofenac’s mature positioning across NSAIDs, (2) competitive intensity from generic NSAID tablets plus branded rivals in acute pain, and (3) payer and formulary behavior that typically compresses net prices after generic penetration.

How does the market size and competition shape CAMBIA pricing power?

Diclofenac potassium sits in the broader NSAID acute pain category. Market structure for NSAIDs is characterized by:

• High generic share: once diclofenac-linked products reach full generic uptake in a geography, list price insulation declines sharply.
• Wholesale and rebate pressure: formularies and pharmacy benefit managers (PBMs) push net price down via rebate contracts, particularly for non-exclusive brands.
• Substitution at the molecule level: CAMBIA’s clinical differentiation (formulation and onset profile claims typical of diclofenac potassium brands) often does not prevent substitution to cheaper diclofenac and non-diclofenac NSAIDs when they sit in lower-cost tiers.

Competitive set (practical substitution logic)

CAMBIA competes for demand with:

• Generic diclofenac products (tablet and other diclofenac forms, depending on local approval and stocking habits)
• Other NSAIDs used for similar indications (e.g., ibuprofen, naproxen, celecoxib in select settings)
• Branded acute pain products that target specialty formularies or specific payer networks

In NSAIDs, switching costs are low for prescribers after therapeutic equivalence is established, so CAMBIA’s financial trajectory tends to track net price after rebates and script volume more closely than wholesale list price.

What market dynamics are most likely to move CAMBIA sales?

Three market levers dominate:

1. Formulary tier placement
   • A move from preferred to non-preferred tiers typically reduces prescription volume and forces higher promotional spend to hold share.
2. Net price compression
   • Even if CAMBIA maintains an above-generic price on a gross basis, net price usually converges toward the payer’s preferred options via rebates and contract pricing.
3. Channel inventory behavior
   • Retail and distributor purchasing patterns can amplify quarterly volatility as manufacturers and wholesalers adjust inventories ahead of competitive shifts or contract renewals.

What is CAMBIA’s financial trajectory signal from a product lifecycle standpoint?

CAMBIA is not a first-in-class launch archetype; it is a mature NSAID brand tied to a molecule with established generic competition risk. That lifecycle typically produces a financial trajectory with:

• Early brand consolidation driven by differentiation messaging and payer contracting
• Mid-stage volume pressure from generic substitution
• Late-stage margin compression as the brand must fund pull-through (detailing, co-pay structures where available, and rebate-backed access)

For CAMBIA specifically, the key practical indicator investors and operators track is:

• Net revenue growth or decline driven by scripts and rebate intensity
• Operating margin trajectory driven by promotional spend versus net price

What does the reported financial performance pattern look like for mature diclofenac brands?

While exact CAMBIA-specific financial line items are not provided in the available material here, the pattern for comparable mature diclofenac brand structures generally follows:

• Net sales plateau or decline after generic penetration
• Gross-to-net deterioration as rebates rise to maintain formulary access
• Marketing expense remaining elevated relative to revenue once competition intensifies

This creates a common outcome for mature NSAID brands:

• Revenue resilience only if the brand sustains differentiated formulation advantages and avoids tier downgrades
• Profitability drift if pricing falls faster than cost reductions

How do patent and exclusivity dynamics influence CAMBIA’s revenue risk?

CAMBIA’s long-term revenue is exposed to:

• Generic entry risk tied to the status of relevant diclofenac potassium patent families and any formulation or method-of-use protections
• Regulatory exclusivity windows if any remain for the specific brand formulation or indication set
• Country-to-country variability in how quickly generics reach pharmacy shelves after approval

Once meaningful generic erosion begins, the brand’s revenue tends to become highly sensitive to:

• Rebate effectiveness and payer contracting execution
• Formulary status in large PBMs
• Gross-to-net management

What operational strategy determines whether CAMBIA maintains financial stability?

For a mature NSAID brand, stability usually depends on:

• Payer access discipline (maintaining favorable tiers with controlled rebate spend)
• Brand execution (prescriber outreach where there is still incremental differentiation)
• Forecast accuracy (inventory and demand matching to reduce channel write-downs)

In practice, the financial trajectory is often better explained by:

• Net revenue per script (price and rebate outcomes)
• Scripts (formulary placement and promotional pull-through) rather than gross price alone.

Market and financial outlook: base case directional view for CAMBIA

Given CAMBIA’s placement in a mature NSAID landscape with molecule-level substitution:

• The base case is limited pricing power and revenue pressure unless CAMBIA preserves payer preference via contracting.
• Margin performance is likely to track rebate intensity and marketing cost discipline more than topline volume.
• Volatility tends to come from contract renewals and channel inventory adjustments, not from clinical adoption shocks.

Key metrics to monitor for CAMBIA (investment and R&D diligence)

Even when topline performance is stable, investors and operators should track:

• Net sales trend (quarterly and trailing twelve months)
• Gross-to-net (rebates and discounts as a % of gross)
• Marketing expense as % of sales
• Formulary access (tier placement outcomes across major PBMs)
• Script momentum (prescription counts in retail and specialty channels where relevant)

Key Takeaways

• CAMBIA is a diclofenac potassium NSAID brand whose financial trajectory is most sensitive to net price compression and formulary tier placement as generic substitution increases.
• The market dynamics in NSAIDs favor low switching costs, so CAMBIA’s revenue performance depends on payer access execution more than on clinical differentiation alone.
• The most decision-relevant signals are net revenue trend, gross-to-net, and marketing intensity, since these determine whether the brand maintains margin as volume stabilizes or declines.
• Patent or exclusivity events (if any remaining) matter mainly as they affect timing of generic erosion and the ability to hold payer preference.

FAQs

1) What drives CAMBIA sales more: pricing or script volume?
Script volume and formulary access typically dominate because payer contracting drives net price down as generic options expand.

2) Why does gross-to-net matter for CAMBIA’s financial trajectory?
Rebates and discounts often rise to sustain access, so gross sales can hold while net revenue and margins erode.

3) How do generic competitors affect CAMBIA immediately?
They usually trigger substitution once at-pharmacy availability and payer rules align, leading to faster script share loss than gross price adjustments can offset.

4) What is the highest-impact lever to defend CAMBIA margins?
Controlling rebate intensity while preserving preferred tier status.

5) What quarterly factors commonly create CAMBIA revenue volatility?
Contract renewals, rebate true-ups, and distributor inventory corrections tied to expected demand and competitive shifts.

References

[1] FDA Orange Book database (diclofenac potassium listings and related patent/exclusivity records). U.S. Food and Drug Administration.
[2] DrugBank: CAMBIA (diclofenac potassium) brand information and drug substance context. DrugBank Online.
[3] PubChem: diclofenac potassium compound profile used for category and mechanism context. National Center for Biotechnology Information (NCBI).