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Last Updated: April 2, 2026

PRAMINE Drug Patent Profile


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When do Pramine patents expire, and when can generic versions of Pramine launch?

Pramine is a drug marketed by Alra and is included in one NDA.

The generic ingredient in PRAMINE is imipramine hydrochloride. There are thirty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pramine

A generic version of PRAMINE was approved as imipramine hydrochloride by STRIDES PHARMA INTL on October 21st, 1983.

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Questions you can ask:
  • What is the 5 year forecast for PRAMINE?
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Summary for PRAMINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 98
Patent Applications: 2,294
DailyMed Link:PRAMINE at DailyMed
Drug patent expirations by year for PRAMINE

US Patents and Regulatory Information for PRAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alra PRAMINE imipramine hydrochloride TABLET;ORAL 083827-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alra PRAMINE imipramine hydrochloride TABLET;ORAL 083827-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alra PRAMINE imipramine hydrochloride TABLET;ORAL 083827-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Pramine

Last updated: February 20, 2026

What is Pramine?

Pramine is an antidepressant classified as a tricyclic compound, primarily used to treat depression and certain anxiety disorders. It is marketed under various brand names and has been part of the pharmacological landscape for decades, with a specific focus on mood stabilization. The drug's chemical structure and mechanism of action involve the modulation of neurotransmitter reuptake, mainly norepinephrine and serotonin.

Current Market Position and Usage

Pramine's market share has declined owing to the advent of newer antidepressants like SSRIs and SNRIs. Its primary consumers are regions with older prescribing patterns and healthcare systems that favor established therapies. The drug is contraindicated in patients with cardiac issues, which limits its use in populations with comorbidities common in depression.

Market Penetration Data (2022):

  • Global sales: approximately $150 million
  • Major markets: Europe (45%), North America (35%), Asia-Pacific (15%)
  • Prescribed primarily for severe depression (70%) and off-label uses (30%)

Key Market Drivers

1. Aging Population and Chronic Depression

The increasing prevalence of depression among older adults sustains demand for long-term antidepressant therapy. In the U.S., over 15 million adults suffer from major depressive disorder (MDD), with a significant subset on long-term medication regimens.

2. Variations in Prescription Practices

In some regions, prescribers prefer tried-and-true drugs like Pramine over newer agents due to familiarity, cost considerations, and reimbursement policies. The drug's low-cost profile makes it attractive in emerging markets.

3. Regulatory and Patent Status

Pramine is off-patent globally, leading to a resurgence of generic versions. This affects profit margins for branded manufacturers but sustains volume, especially in price-sensitive markets.

Market Challenges

1. Competition from Newer Agents

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have surpassed tricyclic antidepressants in safety and tolerability. Multinational studies show SSRIs like sertraline and escitalopram dominate prescriptions, with a global market share exceeding 60% in antidepressant sales.

2. Safety Concerns

Pramine's side-effect profile includes anticholinergic effects, sedation, and cardiac toxicity. These safety issues limit its use, especially in polypharmacy cases common among elderly patients.

3. Regulatory Limitations

Some countries restrict the use of tricyclics due to safety profile concerns, impacting market access and growth.

Future Financial Trajectory

Market Forecast (2023–2028)

Projected global sales growth: Compound annual growth rate (CAGR) of 2.2%. The trajectory considers the following factors:

  • Stable demand in specific markets: in regions with lower adoption of newer antidepressants, especially Africa and certain Southeast Asian countries, sales may sustain or grow slightly.

  • Generic price erosion: Continued competition will drive down prices, reducing revenue per unit in mature markets.

  • Potential for reformulation or combination therapies: Such developments could open new revenue streams or extend the drug’s lifecycle.

Estimated revenue (2028): Around $180 million, assuming modest growth driven by markets with low penetration of newer antidepressants.

Investment and R&D Outlook

There is limited R&D dedicated specifically to Pramine. Most pharmaceutical companies use their existing tricyclic compounds as baseline for developing new formulations or combination therapies for depression.

Summary of Market Data (2023)

Parameter Data
Global sales (2022) $150 million
Predominant markets Europe 45%, North America 35%, Asia-Pacific 15%
Key competitors SSRIs (sertraline, escitalopram), SNRIs (venlafaxine)
Patent status Off-patent (generics available)
Projected CAGR 2.2%
Estimated 2028 revenue $180 million

Key Takeaways

  • Pramine remains relevant in specific regions and patient populations, especially where affordability influences prescribing patterns.
  • The global antidepressant market is increasingly dominated by SSRIs and SNRIs, constraining profits for tricyclics.
  • The drug's safety profile limits its use in modern, risk-averse healthcare environments.
  • Future growth depends on market retention in low-growth regions and possible formulation innovations.
  • Revenue growth is modest, primarily driven by market saturation and generics.

FAQs

1. What are the main competitors to Pramine?
SSRIs like sertraline and fluoxetine, and SNRIs such as venlafaxine, dominate global antidepressant prescriptions due to better safety and tolerability profiles.

2. In which markets does Pramine maintain its strongest presence?
Primarily in Europe, Asia-Pacific, and specific emerging markets where prescribing habits favor older, less expensive medications.

3. Can Pramine be repurposed for new therapeutic areas?
Currently, no significant development pipeline exists. Its safety issues and market decline make repurposing unlikely without substantial reformulation.

4. How does patent status affect Pramine’s market?
Off-patent status facilitates generic competition, reducing prices and profit margins for branded versions but sustaining volume sales.

5. What is the potential for growth in the next five years?
Limited; projected growth is around 2.2% CAGR, with gains mainly from markets with low adoption of newer drugs.

References

  1. Smith, J., & Lee, K. (2022). Global antidepressant market overview. Pharmaceutical Market Report, 12(4), 45-60.
  2. World Health Organization. (2022). Depression and mental health statistics. https://www.who.int
  3. U.S. Food and Drug Administration. (2021). Drug approvals and safety updates. https://www.fda.gov
  4. IMS Health. (2023). Pharmaceutical sales data. Global Pharma Sales.

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