Desipramine hydrochloride - Generic Drug Details

What are the generic drug sources for desipramine hydrochloride and what is the scope of freedom to operate?

Desipramine hydrochloride is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Actavis Totowa, Alembic, Amneal Pharms Co, Ani Pharms, Chartwell Rx, Heritage, Novast Labs, Usl Pharma, and Validus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for desipramine hydrochloride. Ten suppliers are listed for this compound.

Summary for desipramine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	18
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	61
Patent Applications:	2,258
What excipients (inactive ingredients) are in desipramine hydrochloride?	desipramine hydrochloride excipients list
DailyMed Link:	desipramine hydrochloride at DailyMed

Recent Clinical Trials for desipramine hydrochloride

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

Sponsor	Phase
NHS Lothian	Phase 3
University College, London	Phase 3
London North West Healthcare NHS Trust	Phase 3

See all desipramine hydrochloride clinical trials

Pharmacology for desipramine hydrochloride

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for desipramine hydrochloride

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for desipramine hydrochloride

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

US Patents and Regulatory Information for desipramine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	208105-001	Mar 17, 2016	AB	RX	No	No
Alembic	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	209785-006	Jul 7, 2021	AB	RX	No	No
Actavis Totowa	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071601-001	Jun 5, 1987	AB	RX	No	No
Ani Pharms	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	205153-001	Oct 28, 2016		DISCN	No	No
Alembic	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	209785-005	Jul 7, 2021	AB	RX	No	No
Heritage	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	207433-005	May 5, 2016	AB	RX	No	No
Ani Pharms	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071803-004	Dec 8, 1987		DISCN	No	No

Expired US Patents for desipramine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-003	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-005	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-007	Feb 11, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-003	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-006	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-001	Approved Prior to Jan 1, 1982

Desipramine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Desipramine Hydrochloride

Introduction to Desipramine Hydrochloride

Desipramine hydrochloride is a tricyclic antidepressant (TCA) primarily used for the treatment of depression. It is also utilized off-label for various other conditions, including bulimia nervosa, irritable bowel syndrome, neuropathic pain, overactive bladder, postherpetic neuralgia, and ADHD[2].

Market Size and Growth

The global market for antidepressants, including desipramine hydrochloride, is part of the broader mental health treatment market. As of 2024, the global anxiety disorders treatment market, which overlaps with the antidepressant market, is valued at approximately USD 11.59 billion and is expected to grow to USD 15.90 billion by 2032[3].

Segmentation and Market Share

By Drug Class

Selective Serotonin Reuptake Inhibitors (SSRIs) dominate the market with a 32% share in 2022. However, tricyclic antidepressants like desipramine hydrochloride still hold a significant position due to their efficacy in certain patient populations[3].

By Disorder Type

Generalized anxiety disorders hold the largest market share, which indirectly influences the demand for antidepressants like desipramine hydrochloride that are used in treating related conditions[3].

By Treatment Setting

Hospital outpatient settings lead the market with a 71% share, indicating that a significant portion of antidepressant prescriptions, including desipramine hydrochloride, are managed in outpatient care[3].

Geographical Distribution

North America currently dominates the anxiety disorders treatment market, which includes the segment for antidepressants. Europe is expected to grow at a significant rate during the forecast period, potentially increasing the demand for desipramine hydrochloride in these regions[3].

Financial Trajectory

Revenue and Growth Rate

While specific financial data for desipramine hydrochloride is not readily available, the overall antidepressant market is expected to see steady growth. The global anxiety disorders treatment market, which includes antidepressants, is projected to grow from USD 11.59 billion in 2024 to USD 15.90 billion by 2032, indicating a positive financial trajectory for related medications[3].

Cost and Pricing

The cost of desipramine hydrochloride can vary based on the dosage and the healthcare setting. For example, self-pay prices for a 10 mg tablet of desipramine hydrochloride can range from $7.85 to $3.93, depending on the pharmacy and location[5].

Regulatory and Approval Aspects

Desipramine hydrochloride has been FDA-approved for the treatment of depression, and its approval has expanded the treatment options available for managing this condition. Recent approvals and clinical trials, such as the one initiated by VistaGen Therapeutics Inc. for PH94B, indicate ongoing regulatory activities that could impact the market dynamics of antidepressants[3].

Off-Label Uses and Market Expansion

Desipramine hydrochloride's off-label uses in treating bulimia nervosa, irritable bowel syndrome, neuropathic pain, and other conditions contribute to its market presence. The efficacy of desipramine in these areas, such as its antinociceptive properties, helps in expanding its market reach beyond traditional antidepressant uses[2].

Adverse Effects and Monitoring

The broad toxic profile of desipramine hydrochloride, including risks such as increased suicide risk, orthostatic hypotension, and cardiac abnormalities, necessitates careful monitoring. This can impact its market dynamics as healthcare providers may opt for safer alternatives. However, the drug's therapeutic benefits, especially in patients who do not respond to other treatments, maintain its relevance[2].

Pharmacogenomics and Metabolism

Desipramine hydrochloride's metabolism, primarily through CYP2D6 and CYP1A2, and its genetic variability in metabolism can affect its efficacy and safety. This aspect requires careful monitoring and can influence the drug's financial trajectory as it may lead to additional costs for genetic testing and personalized treatment plans[1][2].

Key Takeaways

• Desipramine hydrochloride is part of the growing antidepressant market, expected to reach USD 15.90 billion by 2032.
• The drug has significant off-label uses, expanding its market reach.
• Regulatory approvals and ongoing clinical trials impact its market dynamics.
• Careful monitoring is required due to its broad toxic profile.
• Pharmacogenomic factors influence its efficacy and safety, potentially affecting treatment costs.

FAQs

1. What is the primary use of desipramine hydrochloride?

Desipramine hydrochloride is primarily used for the treatment of depression.

2. What are the off-label uses of desipramine hydrochloride?

Desipramine hydrochloride is used off-label for conditions such as bulimia nervosa, irritable bowel syndrome, neuropathic pain, overactive bladder, postherpetic neuralgia, and ADHD.

3. What are the major adverse effects of desipramine hydrochloride?

Major adverse effects include increased risk of suicide, orthostatic hypotension, cardiac abnormalities, seizures, and anticholinergic side effects.

4. How is desipramine hydrochloride metabolized?

Desipramine hydrochloride is extensively metabolized in the liver by CYP2D6 and CYP1A2, with genetic variability affecting its metabolism.

5. What is the expected growth rate of the antidepressant market?

The global anxiety disorders treatment market, which includes antidepressants, is expected to grow from USD 11.59 billion in 2024 to USD 15.90 billion by 2032.

Cited Sources

1. DrugBank: Desipramine: Uses, Interactions, Mechanism of Action.
2. NCBI Bookshelf: Desipramine - StatPearls.
3. GlobeNewswire: Anxiety Disorders Treatment Market Size to Reach USD 15.90 Bn by 2032.
4. Tocris: Desipramine hydrochloride.
5. Atrium Health: Self-Pay - Atrium Health.