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-eight 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:	42
Clinical Trials:	8
Patent Applications:	4,130
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
Centre for Addiction and Mental Health	Phase 4
National Institute of Mental Health (NIMH)	Phase 4
University of Washington	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	AB	RX	Yes	No
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-004	Approved Prior to Jan 1, 1982	AB	RX	Yes	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

International Patents for PAMELOR

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

Country	Patent Number	Title	Estimated Expiration
Germany	1468341
France	4407
Belgium	650988
Sweden	331992

PAMELOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pamelor (Nortriptyline Hydrochloride)

Introduction to Pamelor

Pamelor, known generically as nortriptyline hydrochloride, is a tricyclic antidepressant used primarily to treat depression and certain types of chronic pain. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth Projections

The global nortriptyline hydrochloride market is anticipated to experience steady growth over the forecast period of 2024-2031. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.3%, increasing from USD 239.7 million in 2023 to USD 287.52 million by 2031[1].

Key Drivers of Market Growth

Increasing Incidences of Depression and Chronic Pain

The rising prevalence of depression and chronic pain conditions, including diabetic neuropathy, is a significant driver of the market. For instance, more than 8% of American adults, approximately 21 million individuals, are affected by depression, according to Mental Health America. This increased prevalence, coupled with the easy accessibility to medications like nortriptyline hydrochloride, supports market growth[1].

Growing Demand from Research and Academic Sectors

The increasing requirement for nortriptyline hydrochloride from research and academic institutions is another key factor. Studies evaluating the potential of nortriptyline hydrochloride for drug repurposing, such as its antitumor activities, are bolstering the demand for this product[1].

High Purity Requirements

The preference for nortriptyline hydrochloride with more than 99% purity, driven by its high efficacy and the needs of medicine manufacturing facilities, is also driving market growth[1].

Regional Market Analysis

North America

The well-established healthcare sector in North America, along with increasing investments in research and development by pharmaceutical, healthcare, and biotechnology companies, is a significant factor in the region's market expansion. The high prevalence of depression and chronic pain in this region further supports the demand for nortriptyline hydrochloride[1].

Global Market

The market is also growing in other regions such as Europe, South America, Asia-Pacific, and the Middle East and Africa, driven by similar factors including the increasing incidence of diabetes and associated conditions like diabetic neuropathy[1].

Competitive Landscape

The global nortriptyline hydrochloride market is characterized by the presence of several key players, including Anant Pharmaceuticals Pvt. Ltd., HRV Global Life Sciences, Vasudha Pharma Chem Ltd., and others. These companies are investing heavily in research and development to meet the growing demand for high-purity nortriptyline hydrochloride[1].

Impact of Generic Competition

The entry of generic versions of nortriptyline hydrochloride can significantly impact the market dynamics. Generic competition, facilitated by the Hatch-Waxman Act, has led to a rapid decline in market share for brand-name drugs upon patent expiration. For example, brand-name drugs that faced generic competition lost an average of 44% of their market share within the first full calendar year after patent expiration[3].

Financial Implications

Revenue and Profitability

The projected growth in the nortriptyline hydrochloride market translates into increased revenue for pharmaceutical companies. However, the impact of generic competition must be considered, as it can erode the expected returns from research and development. According to the Congressional Budget Office, the average returns from marketing a new drug have been lowered by roughly 12% due to increased generic competition[3].

Research and Development Investments

The pharmaceutical industry spends significantly on research and development, with estimates suggesting around USD 160 billion annually. The development of novel medications, including potential new uses for nortriptyline hydrochloride, involves high rates of failure but also significant potential rewards[1].

Clinical Efficacy and Usage

Mechanism of Action

Nortriptyline hydrochloride works by increasing the activity of serotonin in the brain and interfering with the transport, release, and storage of catecholamines. It is not a monoamine oxidase inhibitor and has a combination of stimulant and depressant properties[4].

Comparative Efficacy

Studies have compared the efficacy of nortriptyline hydrochloride with other antidepressants like duloxetine. While duloxetine has shown advantages in addressing anxiety and depression and enhancing the overall quality of life, nortriptyline hydrochloride remains a viable treatment option for endogenous depressions and certain chronic pain conditions[5].

Future Market Scenario

The demand for nortriptyline hydrochloride is expected to increase due to ongoing research and development activities, particularly in the area of drug repurposing. For instance, studies have shown that nortriptyline hydrochloride exhibits significant antitumor activities, which could expand its therapeutic applications[1].

Key Takeaways

• The global nortriptyline hydrochloride market is projected to grow at a CAGR of 2.3% from 2024 to 2031.
• Increasing incidences of depression, chronic pain, and diabetic neuropathy are driving market growth.
• High purity requirements and growing demand from research and academic sectors are key factors.
• The market is influenced by generic competition, which affects the profitability of brand-name drugs.
• Significant investments in research and development are crucial for market expansion.

Frequently Asked Questions (FAQs)

1. What is the primary use of Pamelor (nortriptyline hydrochloride)? Pamelor is primarily used to treat depression and certain types of chronic pain.

2. What is the projected growth rate of the global nortriptyline hydrochloride market? The market is projected to grow at a CAGR of 2.3% from 2024 to 2031.

3. How does generic competition affect the nortriptyline hydrochloride market? Generic competition can significantly erode the market share and profitability of brand-name drugs upon patent expiration.

4. What are the key drivers of the nortriptyline hydrochloride market growth? Key drivers include increasing incidences of depression and chronic pain, growing demand from research and academic sectors, and high purity requirements.

5. Are there any potential new therapeutic applications for nortriptyline hydrochloride? Yes, studies are evaluating the potential of nortriptyline hydrochloride for drug repurposing, including its antitumor activities.

Cited Sources:

1. Global Nortriptyline Hydrochloride Market Size 2031 - MarketsandData
2. Nortriptyline (oral route) - Mayo Clinic
3. HOW INCREASED COMPETITION FROM GENERIC DRUGS HAS AFFECTED PRICES AND RETURNS - Congressional Budget Office
4. Pamelor: Package Insert / Prescribing Information - Drugs.com
5. Comparing the efficacy of duloxetine and nortriptyline in alleviating ... - Frontiers in Psychiatry