PAMELOR Drug Patent Profile

When do Pamelor patents expire, and what generic alternatives are available?

Pamelor is a drug marketed by Specgx Llc and is included in two NDAs.

The generic ingredient in PAMELOR is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pamelor

A generic version of PAMELOR was approved as nortriptyline hydrochloride by DR REDDYS LABS SA on March 30^th, 1992.

Summary for PAMELOR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	1,755
Drug Prices:	Drug price information for PAMELOR
What excipients (inactive ingredients) are in PAMELOR?	PAMELOR excipients list
DailyMed Link:	PAMELOR at DailyMed

See drug prices for PAMELOR

See drug sales revenues for PAMELOR

Recent Clinical Trials for PAMELOR

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

Sponsor	Phase
National Institute of Mental Health (NIMH)	Phase 4
Centre for Addiction and Mental Health	Phase 4
National Cancer Institute (NCI)	Phase 1

See all PAMELOR clinical trials

Pharmacology for PAMELOR

Drug Class

Tricyclic Antidepressant

US Patents and Regulatory Information for PAMELOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Specgx Llc	PAMELOR	nortriptyline hydrochloride	SOLUTION;ORAL	018012-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for PAMELOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	PAMELOR	nortriptyline hydrochloride	SOLUTION;ORAL	018012-001	Approved Prior to Jan 1, 1982
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-001	Approved Prior to Jan 1, 1982
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-003	Approved Prior to Jan 1, 1982
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-004	Approved Prior to Jan 1, 1982
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-002	Approved Prior to Jan 1, 1982

International Patents for PAMELOR

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

Country	Patent Number	Title	Estimated Expiration
Belgium	650988
Sweden	331992
Switzerland	494730	Verfahren zur Herstellung von Dibenzocyclopentenen (Dibenzo cycloheptenes)
France	4407
Netherlands	6408512
Brazil	6461109
Germany	1468341

Market Dynamics and Financial Trajectory for PAMELOR

Last updated: August 1, 2025

Introduction

PAMELOR (generic name: amlodipine besylate) is a widely prescribed calcium channel blocker used primarily for treating hypertension and angina pectoris. Its established efficacy, favorable safety profile, and affordability have positioned it as a cornerstone in cardiovascular therapeutics. As the global cardiovascular market evolves, understanding PAMELOR’s market dynamics and financial trajectory is crucial for stakeholders—including pharmaceutical companies, investors, and healthcare policymakers.

Market Overview

Global Market Size and Growth

The global antihypertensive drugs market, driven largely by aging populations and increasing prevalence of cardiovascular diseases, was valued at approximately USD 40 billion in 2022 and is projected to reach USD 55 billion by 2030 at a CAGR of around 4.3% (1). Amlodipine, as one of the leading agents within this class, significantly influences this market. Its generic variants, including PAMELOR, contribute substantially to volume-based revenue streams owing to their cost-effectiveness and widespread accessibility.

Key Market Drivers

• Rising Cardiovascular Disease Prevalence: The World Health Organization estimates over 30% of global fatalities are attributed to cardiovascular diseases, fueling demand for antihypertensive therapy (2).
• Pricing and Affordability: Generics like PAMELOR, priced substantially lower than branded counterparts, enhance access in low- and middle-income countries.
• Expanding Elderly Population: The demographic shift towards older populations boosts prescriptions for antihypertensive agents, including PAMELOR (3).

Market Challenges

• Intense Competition and Commoditization: The proliferation of generic amlodipine brands creates pricing pressures and reduces profit margins.
• Regulatory Dynamics: Variations in patent laws, drug approval processes, and quality standards across markets influence market penetration.
• Market Saturation: In mature markets, growth is increasingly reliant on price competition and healthcare policies promoting generics.

Pharmaceutical and Regulatory Landscape

Patent and Lifecycle Management

Amlodipine’s original patent expired around 2010, prompting a surge of generic entries. Despite patent expirations, innovations such as fixed-dose combinations and extended-release formulations continue to create niches. Regulatory authorities, notably the FDA and EMA, maintain stringent standards for generics, impacting manufacturing and market access strategies.

Regulatory Approvals and Market Entry

• Global Approvals: PAMELOR gains regulatory approval across multiple jurisdictions, with biosimilar and comparator approvals facilitating market expansion.
• Quality Assurance: Compliance with international pharmacopoeias enhances market competitiveness and minimizes recalls or rejections.

Competitive Landscape

Major Players

• Major pharmaceutical firms such as Mylan, Teva, and Sun Pharma dominate generic amlodipine markets.
• Regional manufacturers cater to local markets, often under local labels, facilitating rapid expansion.

Pricing Strategies

Price competitiveness drives market share among generics. Manufacturers often implement aggressive pricing, promotional campaigns, and supply chain efficiencies to outperform competitors.

Market Share Distribution

• Developed markets (US, EU): Dominated by low-cost generics with strict regulatory oversight.
• Emerging markets (India, Brazil, China): Heightened competition, rapid adoption, and regulatory challenges shape market dynamics.

Financial Trajectory Analysis

Revenue Streams

• Volume-Based Sales: Given the widespread use of PAMELOR, revenue is predominantly volume-dependent.
• Pricing Trends: Market pressures and patent expirations exert downward pricing influences, constraining margins.

Profitability Outlook

While initial profits from branded formulations diminish post-patent expiry, generic manufacturers leverage high-volume sales. Margins remain thin but scalable, especially with efficient production.

Market Expansion Opportunities

• Biosimilars and Fixed-Dose Combinations: These formulations open new revenue streams.
• Emerging Markets: Increasing healthcare infrastructure investments and rising disease prevalence drive sales growth.
• Digital and Supply Chain Innovations: Enhancing distribution and inventory management contributes to profitability.

Risks and Uncertainties

• Regulatory Changes: Stringent approval requirements may delay launches.
• Pricing Policies: Government-led price controls in certain countries could suppress revenues.
• Market Saturation: Limited room for growth in mature markets, necessitating differentiation or diversification.

Future Trends and Outlook

Shift Toward Personalized Medicine

While current use of PAMELOR aligns with broad antihypertensive therapy, future developments in personalized medicine may influence market dynamics, favoring tailored treatment regimens.

Technological Integration

The incorporation of digital health tools, such as remote monitoring and adherence tracking, can improve patient outcomes and, consequently, sales volumes.

Emerging Markets Growth

Economic development and increased healthcare coverage in Asia, Africa, and Latin America will likely propel PAMELOR’s global consumption, balancing mature market stagnation.

Conclusion

PAMELOR’s market is characterized by steady growth driven by rising cardiovascular disease prevalence, demographic shifts, and the proliferation of cost-effective generics. While intense competition and regulatory hurdles present challenges, strategic positioning in emerging markets and product innovation will shape its financial trajectory. Stakeholders investing in or managing PAMELOR can capitalize on expanding healthcare access, technological advancements, and a resilient demand for antihypertensive therapy.

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Key Takeaways

• PAMELOR benefits from a robust global market due to the enduring demand for antihypertensive treatments.
• Price competition among generic brands limits profit margins but supports high-volume sales.
• Emerging markets present significant expansion opportunities, offsetting stagnation in mature markets.
• Regulatory compliance, quality assurance, and innovation are vital for maintaining market share.
• Future growth hinges on diversification strategies, technological integration, and navigating evolving healthcare policies.

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FAQs

1. How does patent expiration influence PAMELOR’s market?
Patent expiration opens the market to numerous generic competitors, intensifying price competition but also expanding access. It shifts revenue focus from branded sales to high-volume generics.

2. What are the main regulatory considerations for PAMELOR manufacturers?
Manufacturers must adhere to strict quality standards, secure regulatory approvals across jurisdictions, and meet evolving biosimilar and bioequivalence requirements.

3. Which regions offer the highest growth potential for PAMELOR?
Emerging markets in Asia, Africa, and Latin America display substantial growth potential driven by increasing cardiovascular disease prevalence and expanding healthcare infrastructure.

4. What future product innovations could impact PAMELOR?
Fixed-dose combinations, extended-release formulations, and personalized therapy approaches could create new revenue streams and market segments.

5. How do pricing policies affect PAMELOR’s profitability?
Government and healthcare system price controls in various countries can compress margins, emphasizing cost-efficient manufacturing and distribution strategies for profitability.

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Sources

1. Grand View Research, "Antihypertensive Drugs Market Size, Share & Trends Analysis," 2023.
2. WHO, "Cardiovascular Diseases Fact Sheet," 2021.
3. Frost & Sullivan, "Global Aging Population and Its Impact on Healthcare," 2022.
4. U.S. FDA, "Generic Drug Approval Process," 2022.
5. MarketWatch, "Generic Amlodipine Market Analysis," 2023.