Amoxapine - Generic Drug Details

What are the generic sources for amoxapine and what is the scope of patent protection?

Amoxapine is the generic ingredient in two branded drugs marketed by Chartwell Rx, Watson Labs, Watson Pharms Teva, and Lederle, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for amoxapine. Two suppliers are listed for this compound.

Summary for amoxapine

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	4
Patent Applications:	6,799
Drug Prices:	Drug price trends for amoxapine
What excipients (inactive ingredients) are in amoxapine?	amoxapine excipients list
DailyMed Link:	amoxapine at DailyMed

See drug prices for amoxapine

Recent Clinical Trials for amoxapine

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Alexza Pharmaceuticals, Inc.	Phase 1

See all amoxapine clinical trials

Pharmacology for amoxapine

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for amoxapine

Adrenergic Uptake Inhibitors

Antidepressive Agents, Second-Generation

Dopamine Antagonists

Neurotransmitter Uptake Inhibitors

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for amoxapine

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for amoxapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	AMOXAPINE	amoxapine	TABLET;ORAL	072879-001	Jun 28, 1991		DISCN	No	No
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	AMOXAPINE	amoxapine	TABLET;ORAL	072691-002	Aug 28, 1992		RX	No	No
Chartwell Rx	AMOXAPINE	amoxapine	TABLET;ORAL	072879-002	Jun 28, 1991		DISCN	No	No
Watson Labs	AMOXAPINE	amoxapine	TABLET;ORAL	072691-004	Aug 28, 1992		RX	No	No

Expired US Patents for amoxapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-004	Approved Prior to Jan 1, 1982	3,546,226
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-002	Approved Prior to Jan 1, 1982	3,663,696
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982	3,681,357
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-001	Approved Prior to Jan 1, 1982	3,546,226
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982	3,546,226
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-004	Approved Prior to Jan 1, 1982	3,663,696
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-002	Approved Prior to Jan 1, 1982	3,681,357

Amoxapine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amoxapine

Introduction

Amoxapine, an oral antidepressant, is used to treat the symptoms of depression by increasing the levels of certain chemicals in the brain. Here, we will delve into the market dynamics and financial trajectory of amoxapine, considering its place within the broader antidepressant and antipsychotic drug markets.

Market Overview of Antidepressant Drugs

The antidepressant drugs market is a significant segment within the pharmaceutical industry. As of 2024, this market is projected to reach USD 20.1 billion and is anticipated to grow to USD 26.9 billion by 2033, with a CAGR of 3.3%[3].

Position of Amoxapine in the Market

Amoxapine, while not as widely used as some other antidepressants like SSRIs (Selective Serotonin Reuptake Inhibitors), still holds a niche position. It is classified as a tricyclic antidepressant (TCA) and is also known for its antipsychotic properties, making it useful in treating certain cases of depression and schizophrenia.

Historical Data and Market Size

Historical data on the specific market size of amoxapine is not as readily available as for the broader antidepressant market. However, it is part of the larger antidepressant market, which has seen steady growth. The global antidepressant market's growth is driven by factors such as increased awareness and diagnosis rates, innovative treatments, and the expansion of telehealth services[3].

Competitive Landscape

The antidepressant market is highly competitive, with several major players including Pfizer, Inc., Glaxo SmithKline, Plc, Eli Lilly & Co., and others. Amoxapine, being a generic drug, faces competition from both branded and generic versions of other antidepressants.

Key Players

Major pharmaceutical companies like Bristol-Myers Squibb Company, Pfizer, Inc., and Glaxo SmithKline, Plc dominate the market. However, generic drug manufacturers also play a crucial role, especially as patents expire and generic versions become available[1].

Financial Trajectory

Revenue Projections

While specific revenue projections for amoxapine are not available, the overall antidepressant market is expected to grow significantly. The US market, for instance, is projected to reach USD 8.6 billion in 2024 and grow at a CAGR of 3.1% over the forecast period[3].

Generic Drug Dynamics

The generic drug industry, which includes amoxapine, is characterized by declining prices with increasing competition. Generic drug prices fall as the number of competitors increases, but they remain above long-run marginal costs until there are 8 or more competitors[4].

Market Trends and Drivers

Increased Use of Telepsychiatry

The growth of telehealth services, including telepsychiatry, has made mental health care more accessible, driving demand for antidepressants like amoxapine[3].

Innovative Treatments

The development of fast-acting medications and customized therapies is another driver of the antidepressant market. However, amoxapine, being an older drug, may not benefit directly from these innovations but can still maintain its market share due to its established use.

Side Effects and Stigma

The side effects of many antidepressants, including amoxapine, and the stigma surrounding mental health can impact treatment adherence and seeking behavior. Amoxapine, for example, can cause agitation, irritability, and suicidal thoughts, which may affect its usage rates[5].

Regional Market Analysis

North America

North America, particularly the US, is a leading region in the antidepressant drugs market, accounting for 47.9% of the global revenue share in 2024. This region is expected to continue driving the market due to high awareness and diagnosis rates, as well as advanced healthcare infrastructure[3].

Regulatory Environment

FDA Approval and Generic Entry

The FDA's regulatory policies significantly impact the generic drug market. For instance, increased scrutiny of generic drug applications can raise the cost of obtaining approval, affecting the entry of new generic competitors. Simultaneous approval of multiple generic entrants can also influence market dynamics, leading to lower prices but potentially fewer entrants over time[4].

Risks and Challenges

Anticholinergic Effects

Amoxapine, like other antipsychotic and antidepressant drugs, has anticholinergic properties. Long-term exposure to anticholinergic drugs has been associated with an increased risk of dementia, which could impact its long-term use and market trajectory[2].

Medical Precautions

Amoxapine's use is cautioned in patients with certain medical conditions such as bipolar disorder, heart disease, glaucoma, and urinary retention. These precautions can limit its market potential compared to drugs with fewer contraindications[5].

Key Takeaways

• Market Growth: The antidepressant market, including amoxapine, is expected to grow steadily, driven by increased awareness and innovative treatments.
• Competition: Amoxapine faces competition from both branded and generic antidepressants, with prices declining as the number of competitors increases.
• Regional Focus: North America is a key region driving the market, with high awareness and advanced healthcare infrastructure.
• Regulatory Impact: FDA policies on generic drug approvals can significantly affect the market dynamics and entry of new competitors.
• Health Risks: Long-term use of amoxapine and other anticholinergic drugs is associated with increased dementia risk, which could impact its market.

FAQs

Q: What is the primary use of amoxapine?

A: Amoxapine is primarily used to treat the symptoms of depression by increasing the levels of certain chemicals in the brain.

Q: How does the generic drug market impact amoxapine?

A: The generic drug market dynamics, such as declining prices with increasing competition, significantly impact amoxapine. Prices fall as the number of competitors increases, but remain above long-run marginal costs until there are 8 or more competitors.

Q: What are the major drivers of the antidepressant market?

A: The major drivers include increased awareness and diagnosis rates, innovative treatments like fast-acting medications and customized therapies, and the expansion of telehealth services.

Q: What are the potential risks associated with long-term use of amoxapine?

A: Long-term exposure to amoxapine, which has anticholinergic properties, is associated with an increased risk of dementia.

Q: How does the regulatory environment affect the market for amoxapine?

A: FDA policies on generic drug approvals can raise the cost of obtaining approval and influence the timing and number of generic entrants, thereby affecting market prices and competition.

Sources

1. Business Wire: Global Antipsychotic Drugs Market Analysis & Trends 2014-2016[1]
2. JAMA Network: Anticholinergic Drug Exposure and the Risk of Dementia[2]
3. GlobeNewswire: Antidepressant Drugs Market is expected to reach a revenue of USD 26.9 Bn by 2033 at 3.3% CAGR[3]
4. Federal Trade Commission: Generic Drug Industry Dynamics[4]
5. Mayo Clinic: Amoxapine (oral route) - Description[5]