CAMBIA Drug Patent Profile

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

Cambia is a drug marketed by Assertio 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-four 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:	58
Clinical Trials:	3
Patent Applications:	4,737
Drug Prices:	Drug price information 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	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes			Y	Y
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes			Y
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes			Y	Y

Expired US Patents for CAMBIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009

International Patents for CAMBIA

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

Country	Patent Number	Title	Estimated Expiration
China	101272768	Diclofenac formulations and methods of use
Russian Federation	2008101784	СОСТАВЫ, СОДЕРЖАЩИЕ ДИКЛОФЕНАК, И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Taiwan	200740470	Diclofenac formulations and methods of use

Market Dynamics and Financial Trajectory for CAMBIA

Introduction

CAMBIA, a non-steroidal anti-inflammatory drug (NSAID) formulated as diclofenac potassium for oral solution, was approved by the U.S. Food and Drug Administration (FDA) in June 2009 for the acute treatment of migraine attacks with or without aura. Here, we delve into the market dynamics and financial trajectory of CAMBIA, highlighting its impact, market trends, and economic contributions.

Market Need and Demand

Migraine is a significant health issue affecting over 36 million people in the United States, with 75% of those affected being women. Many migraine sufferers are dissatisfied with their current treatments, creating a substantial market need for effective and rapid relief options[4].

Product Unique Selling Points

CAMBIA is engineered using Dynamic Buffering Technology (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A. This technology allows for fast and effective relief from migraine symptoms by quickly achieving peak plasma concentrations without increasing the patient’s total exposure to diclofenac. Clinical trials have shown that CAMBIA is superior to placebo in all four FDA-mandated co-primary end points for migraine—pain, nausea, photophobia, and phonophobia[4].

Market Launch and Reception

The U.S. launch of CAMBIA in 2010 marked an important milestone for Nautilus Neurosciences, Inc., the company behind the drug. The launch was seen as a significant addition to the treatment options available for migraine sufferers, offering rapid onset of pain relief with an established safety profile[4].

Competitive Landscape

The migraine treatment market is competitive, with various prescription and over-the-counter medications available. However, CAMBIA's unique formulation and rapid action set it apart. The drug's ability to provide relief within 15 minutes and maintain efficacy for up to 24 hours makes it a valuable option for patients seeking quick and effective treatment[4].

Financial Performance and Projections

While specific financial data for CAMBIA is not publicly detailed, the broader pharmaceutical market trends can provide context. Prescription drug spending, including for migraine treatments, is expected to rise significantly. For 2024, overall prescription drug spending is projected to increase by 10.0% to 12.0%, with clinics and hospitals anticipating an 11.0% to 13.0% increase[3].

Given CAMBIA's niche in the migraine treatment market and its unique selling points, it is likely to benefit from these trends. The drug's approval and commercialization have established it as a key player in the neurology-focused specialty pharmaceutical sector.

Economic Contributions

Although CAMBIA's direct economic contributions are not separately reported, the overall economic impact of pharmaceutical companies like Nautilus Neurosciences and their partners can be substantial. For instance, Cambia Health Solutions, a different entity but relevant in the healthcare sector, generated $1.7 billion in regional economic activity in 2020, supporting nearly 9,400 jobs and $676 million in labor income[2][5].

Example of Economic Impact

While not directly related to CAMBIA, the economic impact of similar pharmaceutical companies can be illustrative. Every $1 million spent by Cambia Health Solutions, for example, supported an additional $700,000 of economic activity across the region. This kind of economic multiplier effect can be expected in the broader pharmaceutical industry, including companies like Nautilus Neurosciences[2].

Regulatory and Policy Environment

The regulatory environment plays a crucial role in the financial trajectory of pharmaceuticals. CAMBIA's FDA approval was based on rigorous clinical trials, and ongoing regulatory compliance is essential for its continued market presence. Changes in healthcare policies and potential new legislation can also influence drug spending and market dynamics[3].

Future Growth and Challenges

The future growth of CAMBIA will depend on several factors, including new drug approvals, patent expirations, and changes in healthcare policies. The increasing demand for effective migraine treatments and the drug's unique formulation position it for continued market relevance. However, challenges such as competition from new treatments and potential changes in reimbursement policies must be navigated[3].

Key Takeaways

• Market Need: CAMBIA addresses a significant need for effective migraine treatments.
• Unique Selling Points: CAMBIA's rapid action and safety profile set it apart in the market.
• Financial Performance: While specific data is not available, the drug is likely to benefit from rising prescription drug spending trends.
• Economic Contributions: The broader pharmaceutical industry contributes significantly to regional economies.
• Regulatory Environment: Ongoing regulatory compliance is crucial for market presence.
• Future Growth: CAMBIA is positioned for growth but must navigate market challenges.

FAQs

What is CAMBIA used for?

CAMBIA is used for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older[4].

How does CAMBIA work?

CAMBIA uses Dynamic Buffering Technology (DBT) to achieve fast and effective relief from migraine symptoms by quickly achieving peak plasma concentrations without increasing the patient’s total exposure to diclofenac[4].

What are the key benefits of CAMBIA?

CAMBIA offers rapid onset of pain relief, with efficacy within 15 minutes and lasting up to 24 hours. It also has an established safety profile[4].

How does CAMBIA compare to other migraine treatments?

CAMBIA's unique formulation and rapid action set it apart from other treatments, making it a valuable option for patients seeking quick and effective relief[4].

What are the potential future challenges for CAMBIA?

CAMBIA may face challenges from new treatments, changes in healthcare policies, and potential changes in reimbursement policies[3].

Sources

1. Cambia Health Solutions | 2024 | State IDN Profiles | Clarivate
2. Cambia Economic Contributions Report 2020
3. National trends in prescription drug expenditures and projections for 2024
4. Nautilus Neurosciences, Inc. Announces U.S. Launch of CAMBIA
5. Economic Impact | Cambia Health Solutions