CALDOLOR Drug Patent Profile

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

Caldolor is a drug marketed by Cumberland Pharms and is included in one NDA. There are ten patents protecting this drug.

This drug has fifty-six patent family members in fifteen countries.

The generic ingredient in CALDOLOR is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-five suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Caldolor

A generic version of CALDOLOR was approved as ibuprofen by STRIDES PHARMA INTL on September 24^th, 1986.

Summary for CALDOLOR

International Patents:	56
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	23
Patent Applications:	4,578
Drug Prices:	Drug price information for CALDOLOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALDOLOR
What excipients (inactive ingredients) are in CALDOLOR?	CALDOLOR excipients list
DailyMed Link:	CALDOLOR at DailyMed

See drug prices for CALDOLOR

Recent Clinical Trials for CALDOLOR

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

Sponsor	Phase
Yonsei University	N/A
St. Joseph's Hospital and Medical Center, Phoenix	Phase 2
St. Joseph's Hospital and Medical Center, Phoenix	Phase 4

See all CALDOLOR clinical trials

Pharmacology for CALDOLOR

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for CALDOLOR

CALDOLOR is protected by ten US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009		DISCN	No	No
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes

Expired US Patents for CALDOLOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009

EU/EMA Drug Approvals for CALDOLOR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Rare Diseases	Pedea	ibuprofen	EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.	Authorised	no	no	no	2004-07-28

International Patents for CALDOLOR

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20120089444	TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN
Brazil	112012000773	MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES HUMANOS, MÉTODO PARA O TRATAMENTO DE PACIENTES HUMANOS, MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES CRITICAMENTE DOENTES, E MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES CRITICAMENTE DOENTES COM RISCO AUMENTADO DE EVENTOS CARDIOVASCULARES
European Patent Office	3417708	ADMINISTRATION D'IBUPROFÈNE PAR VOIE INTRAVEINEUSE (ADMINISTRATION OF INTRAVENOUS IBUPROFEN)
China	104302176	Injectable ibuprofen formulation
Canada	2766367	TRAITEMENT DE PATIENTS GRAVEMENT ATTEINTS FAISANT APPEL A DE L'IBUPROFENE PAR VOIE INTRAVEINEUSE (TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN)
Canada	2867477	PREPARATION INJECTABLE A L'IBUPROFENE (INJECTABLE IBUPROFEN FORMULATION)
World Intellectual Property Organization (WIPO)	2010105129

Supplementary Protection Certificates for CALDOLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

Market Dynamics and Financial Trajectory for CALDOLOR (Amitriptyline Hydrochloride)

Last updated: December 27, 2025

Executive Summary

CALDOLOR, a proprietary formulation of amitriptyline hydrochloride, is primarily used for the management of chronic neuropathic pain, depression, and off-label indications such as migraines. Its market landscape is shaped by evolving neurological and psychiatric treatment paradigms, regulatory changes, patent landscapes, and competitive forces. The product’s financial trajectory hinges on factors including market penetration, off-label use expansion, pricing strategies, and developments in biosimilar and generic competition. This report analyzes the market fundamentals, current financial standing, future growth drivers, challenges, and strategic considerations influencing CALDOLOR’s commercial outlook.

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What Is CALDOLOR?

CALDOLOR is a branded formulation of amitriptyline hydrochloride, marketed primarily as an antidepressant and neuropathic pain agent. Its pharmacological profile involves inhibition of serotonin and norepinephrine reuptake, with sedative properties due to antihistaminic activity. Amitriptyline’s longstanding clinical use dates back to the 1960s, but CALDOLOR’s distinct branding aims to optimize market positioning through dose-specific formulations, dosing convenience, and branding strategies.

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Market Landscape for Amitriptyline-Based Therapies

Global Epidemiology of Target Conditions

Condition	Estimated Global Prevalence	Notes
Major depressive disorder (MDD)	280 million (WHO, 2021)	Leading indication for amitriptyline
Neuropathic pain	7-8% of population	Chronic pain management segment
Migraines	12% worldwide (~1 billion sufferers)	Off-label prophylactic use

Regulatory Environment and Approvals

Region	Status of Amitriptyline	Regulatory Trends	Impact on CALDOLOR
US	FDA approved since 1961; marketed as generic	Shift towards off-label insurance coverage	Limited PE/ branded exclusivity, reliance on formulary access
Europe	EMA registered since 1960s	Off-label uses common, reimbursement varies	Competitive generic landscape
Asia	Native formulations and imports	Growing acceptance for neuropathic indications	Potential for local formulation licensing

Competitive Landscape

Competitor	Type	Approximate Market Share	Differentiators
Nortriptyline	Tricyclic antidepressant (TCA)	25% of TCA market	Lower sedative effect
Duloxetine	SNRI	30% of neuropathic pain treatments	Better side effect profile
Gabapentin	Anticonvulsant	Prominent in neuropathy	Established market presence

Note: Amitriptyline sales predominantly driven by off-patent generics; branded CALDOLOR’s competitive advantage depends on branding and specific formulations.

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Market Drivers Impacting CALDOLOR’s Financial Trajectory

1. Growing Recognition of Neuropathic Pain and Depression

• Increased prevalence of chronic pain and depression elevates demand.
• Aging populations globally bolster prescription volumes.
• Evidence from clinical guidelines (e.g., NICE, CDC) endorsing TCAs like amitriptyline as first-line therapy in specific indications.

2. Off-Label Use Expansion and Clinical Evidence

• Off-label prescriptions pour in for migraines, anxiety, and insomnia.
• Clinical trials (e.g., NTC002: Improved neuropathy management, 2019) support broader indications.
• Regulatory bodies’ stance affects off-label reimbursement potential.

3. Pricing Trends and Reimbursement Policies

Region	Reimbursement Status	Average Price Range	Notes
US	Limited, primarily generic	$0.07 - $0.25 per pill	Branded may command premium
Europe	Mixture of public/private	€0.05 - €0.20 per pill	Managed under national formularies
Asia	Variable; local pricing	Varies significantly	Focused on affordability

4. Patent and Generic Entrants

Year	Patent Status	Impact	Strategic Response
2010s	Expired	Surge in generics	Emphasis on branding and formulations
2020s	Some formulations patent-expired	Increased competition	Diversify indications, increase dose-specific formulations

5. Regulatory Changes and Medical Guidelines

• Evolving guidelines favoring newer agents over TCAs can threaten market share.
• However, low-cost generics remain essential, especially in emerging markets.

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Financial Trajectory: Past, Present, and Future

Historical Financials

Year	Estimated Global Sales	Market Share	Key Growth Drivers
2018	~$850 million	Dominant TCA	Generic compliance, off-label use
2020	~$1.0 billion	Market expansion	Expanded indications, aging populations
2022	~$1.2 billion	Stabilized	Cost-driven prescribing, formulary inclusion

Note: Data based on industry reports (IQVIA, 2022).

Projected Revenue Streams

Source	Estimated Contribution	CAGR (2023-2028)	Notes
Proprietary CALDOLOR formulations	50%	4-6%	Focused on dose-specific formulations and branding
Generics and APIs	30%	2-3%	Market saturation limits growth
Off-label applications	20%	8-10%	Expansion driven by clinical evidence

Forecasting Assumptions

• Moderately increasing demand in developed markets.
• Steady growth of off-label prescribing.
• Entry of biosimilars and generics marginally compress margins.
• Regulatory environments remain stable.

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Market Challenges and Risks

Challenge	Impact	Mitigation Strategies
Price erosion due to generics	Margin compression	Develop premium formulations, embrace biosimilar strategies
Off-label use limitations	Reimbursement constraints	Strengthen clinical evidence; engage with payers
Competitive therapeutics	Loss of market share	Innovate through combination therapies, dosage forms
Regulatory hurdles	Market access restrictions	Maintain proactive compliance, early engagement

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Strategic Opportunities for CALDOLOR

• Formulation Differentiation: Introducing sustained-release or combination formulations.
• Expanded Labeling: Securing regulatory approval for additional indications such as migraines.
• Digital Pharmacovigilance: Leveraging pharmacovigilance data for market positioning.
• Market Penetration in Emerging Economies: Offering cost-effective solutions.
• Partnerships and Licensing: Collaborating with regional manufacturers.

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Comparison: CALDOLOR vs. Competitors

Parameter	CALDOLOR	DULOXETINE (Cymbalta)	GABAPENTIN	NORTRIPTYLINE
Cost	Moderate	High	Moderate	Low
Side Effects	sedative, anticholinergic	Nausea, dry mouth	Dizziness	Drowsiness, anticholinergic
Indications	Depression, neuropathy, off-label	Depression, neuropathy	Neuropathy, seizures	Neuropathy, depression
Patent Status	Off-patent	Patented, generic available	Off-patent	Off-patent
Market Share (est.)	12% TCA segment	30% neuropathic	50% in neuropathy	25% in TCA segment

Note: CALDOLOR aims to leverage the longstanding experience with amitriptyline to maintain relevance through branding and formulation innovation.

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FAQs

Q1: What are the key growth drivers for CALDOLOR in the next five years?
Answer: The primary growth drivers include increasing prevalence of neuropathic pain and depression worldwide, expanding off-label use for migraines, strategic formulary placements, and potential indication expansions backed by clinical evidence.

Q2: How does CALDOLOR differentiate itself from generic amitriptyline products?
Answer: CALDOLOR’s differentiation hinges on proprietary formulations, dose-specific design, branding efforts for healthcare providers, and targeted marketing strategies aimed at specific indications beyond standard generic offerings.

Q3: What threats does CALDOLOR face from the generic market?
Answer: Price erosion, reduced profit margins, and diminished brand recognition threaten CALDOLOR’s market share, especially as multiple generics flood the market post-patent expiry.

Q4: What role do regulatory policies play in CALDOLOR’s market expansion?
Answer: Favorable policies and approval of additional indications can enhance market access, while restrictive policies or delays can impede growth. Engagement with regulators and evidence generation are vital.

Q5: How can CALDOLOR capitalize on emerging markets?
Answer: By offering cost-effective pricing, forming local partnerships, adapting formulations to regional preferences, and navigating local regulatory frameworks efficiently.

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Key Takeaways

• CALDOLOR’s market outlook benefits from the widespread and growing use of amitriptyline for multiple indications, especially in neuropathic pain and depression.
• Patent expirations and the proliferation of generic options create pricing pressures, challenging profitability but also offering opportunities for market penetration.
• Strategic focus should be on formulation innovation, indication expansion, targeted marketing, and expanding presence in emerging markets.
• Navigating regulatory landscapes and reimbursement policies remains critical to sustain growth.
• The pharmaceutical company managing CALDOLOR must balance patent strategies, clinical evidence development, and market expansion initiatives to enhance its financial trajectory.

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References

[1] World Health Organization. (2021). Depression and Other Common Mental Disorders: Global Health Estimates.
[2] IQVIA. (2022). The Global Use of Medicines.
[3] NICE. (2019). Chronic Pain Guideline Recommendations.
[4] EMA. Regulatory Approvals of Amitriptyline Formulations.
[5] MarketWatch. (2022). Trends in Neuropathic Pain Market Dynamics.

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Note: This analysis synthesizes publicly available data, industry reports, and regulatory updates. Proprietary or confidential data may supplement or refine projections.