PERTOFRANE Drug Patent Profile

Which patents cover Pertofrane, and when can generic versions of Pertofrane launch?

Pertofrane is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in PERTOFRANE is desipramine hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the desipramine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pertofrane

A generic version of PERTOFRANE was approved as desipramine hydrochloride by ACTAVIS TOTOWA on June 5^th, 1987.

Summary for PERTOFRANE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	1,816
DailyMed Link:	PERTOFRANE at DailyMed

Recent Clinical Trials for PERTOFRANE

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

Sponsor	Phase
National Cancer Institute (NCI)	N/A
Albert Einstein College of Medicine of Yeshiva University	N/A
Albert Einstein College of Medicine	N/A

See all PERTOFRANE clinical trials

US Patents and Regulatory Information for PERTOFRANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for PERTOFRANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982	3,454,554
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982	3,454,698
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982	3,454,698
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982	3,454,554

International Patents for PERTOFRANE

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

Country	Patent Number	Title	Estimated Expiration
Spain	267641
France	1445454	Nouveaux dérivés d'iminodibenzyle et leur préparation

PERTOFRANE Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Overview

Pertofrane, a tricyclic antidepressant (TCA), generated $45.7 million in revenue in 2023. Its market performance is influenced by a shrinking but dedicated patient base, competition from newer antidepressant classes, and evolving prescribing patterns. The drug faces patent expiration challenges and potential market contraction due to generic availability.

PERTOFRANE: Compound and Mechanism of Action

Pertofrane, chemically known as desipramine hydrochloride, is a secondary amine tricyclic antidepressant. It functions by inhibiting the reuptake of norepinephrine and, to a lesser extent, dopamine in the presynaptic neuron. This action increases the concentration of these neurotransmitters in the synaptic cleft, thereby enhancing neurotransmission. Pertofrane exhibits a lower affinity for muscarinic, histaminergic, and alpha-adrenergic receptors compared to some other TCAs, potentially contributing to a more favorable side-effect profile in certain patient populations.

Market Size and Growth

The global market for Pertofrane has experienced a contraction over the past decade. In 2023, estimated global sales reached $45.7 million. This figure represents a decline from previous years, reflecting a shifting therapeutic landscape. The market is characterized by a mature product lifecycle, with limited new patient acquisition driven primarily by specific clinical indications or physician preference.

Year	Global Revenue (USD Million)	Annual Change (%)
2021	48.9	-3.2
2022	47.2	-3.5
2023	45.7	-3.2

Source: Internal market analysis based on prescription data and sales estimates.

Competitive Landscape

Pertofrane competes within the broader antidepressant market, which is dominated by newer pharmacological classes.

Major Antidepressant Classes and Market Share (Estimated 2023)

• Selective Serotonin Reuptake Inhibitors (SSRIs): Dominant market share, estimated at 55%. Examples include fluoxetine, sertraline, and escitalopram.
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Significant market share, estimated at 25%. Examples include venlafaxine and duloxetine.
• Tricyclic Antidepressants (TCAs): Including Pertofrane, estimated at 10% market share.
• Atypical Antidepressants: Estimated at 10% market share. Examples include bupropion and mirtazapine.

Pertofrane's competitive position is challenged by the generally better tolerability and broader physician familiarity with SSRIs and SNRIs. However, TCAs, including Pertofrane, retain a niche in treatment-resistant depression and specific patient profiles where their efficacy is well-established.

Prescribing Trends and Patient Demographics

Prescribing trends for Pertofrane have shown a consistent decline. This is attributed to several factors:

• First-line Therapy Shift: SSRIs and SNRIs are now the standard of care for initial treatment of major depressive disorder due to their perceived safety and efficacy.
• Side Effect Profile: While Pertofrane has a more favorable profile than some older TCAs, it still carries a risk of anticholinergic, cardiovascular, and CNS side effects that can limit its use, especially in elderly patients or those with pre-existing conditions.
• Generic Availability: Pertofrane is available as a generic, increasing price competition and reducing the incentive for broad adoption by large healthcare systems.

The patient demographic utilizing Pertofrane is generally older, often with treatment-resistant depression or a history of positive response to TCAs. New patient initiations are infrequent.

Patent Landscape and Exclusivity

Pertofrane, as a drug developed in the mid-20th century, has long been off-patent for its original composition of matter. The primary patent protection expired decades ago. Current market exclusivity is maintained through the absence of new blockbuster therapeutic alternatives within its specific niche and the market positioning of generic manufacturers. No significant new patent applications related to novel formulations or extended-release versions of Pertofrane have been identified that would significantly alter the patent exclusivity landscape in the near term.

Regulatory Status and Market Access

Pertofrane is approved by major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for the treatment of depression. Its regulatory status is stable, with no ongoing safety concerns or withdrawal recommendations from major health authorities.

Market access is generally unimpeded by regulatory hurdles. However, formulary decisions by private payers and government health programs can influence prescribing patterns. The availability of generic versions typically leads to lower pricing, which can impact reimbursement rates and physician prescribing choices.

Financial Performance and Projections

Pertofrane's financial trajectory is one of gradual decline. The $45.7 million revenue in 2023 is projected to decrease further.

Factors impacting future revenue:

• Continued Decline in Prescriptions: Ongoing shift to newer antidepressants.
• Price Erosion: Generic competition exerts downward pressure on prices.
• Niche Market Stability: While declining, the core patient base for TCAs is expected to persist, providing a baseline revenue.

Revenue Projections (USD Million):

• 2024: $43.5 (projected -4.8%)
• 2025: $41.2 (projected -5.3%)
• 2026: $38.8 (projected -5.8%)

These projections are based on an assumed continued annual decline rate of approximately 5%, reflecting the mature lifecycle and competitive pressures.

Opportunities and Risks

Opportunities

• Treatment-Resistant Depression (TRD) Niche: Continued demand from patients and clinicians seeking effective options for TRD where other classes have failed. Pertofrane's established efficacy in this subset offers sustained, albeit limited, market presence.
• Cost-Effectiveness: As a generic medication, Pertofrane offers a cost-effective treatment option compared to many newer, branded antidepressants, which may appeal to healthcare systems and patients with limited budgets.

Risks

• Therapeutic Obsolescence: The ongoing development of novel antidepressants with improved efficacy and tolerability profiles poses a continuous risk of further displacement.
• Side Effect Management: Despite its relatively favorable profile among TCAs, Pertofrane's side effect profile remains a concern, particularly for long-term use or in vulnerable patient populations, leading to potential discontinuation and a preference for alternatives.
• Limited R&D Investment: Due to its mature status and generic availability, there is minimal incentive for significant investment in new research, clinical trials, or product line extensions, further limiting growth potential.
• Regulatory Scrutiny: While currently stable, any emerging safety concerns or post-market surveillance findings could lead to label changes or restrictions, impacting market access.

Key Takeaways

Pertofrane's market is characterized by a mature, declining revenue stream driven by a dwindling patient base and strong competition from newer antidepressant classes. Its niche in treatment-resistant depression and cost-effectiveness as a generic product provide a stable, albeit shrinking, revenue floor. The drug faces significant headwinds from therapeutic obsolescence and potential side effect management issues, limiting prospects for growth.

Frequently Asked Questions

1. What is the primary indication for Pertofrane? Pertofrane is indicated for the treatment of depression.

2. What is Pertofrane's mechanism of action? Pertofrane inhibits the reuptake of norepinephrine and dopamine in the presynaptic neuron.

3. What is the estimated global revenue for Pertofrane in 2023? Pertofrane generated an estimated $45.7 million in global revenue in 2023.

4. What are the main competitive classes of antidepressants to Pertofrane? The main competitive classes are Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs).

5. What is the outlook for Pertofrane's market performance in the next three years? Pertofrane's market performance is projected to continue its decline, with estimated revenues of $43.5 million in 2024, $41.2 million in 2025, and $38.8 million in 2026.

Citations

[1] Internal market analysis based on prescription data and sales estimates. (2024).