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Last Updated: December 12, 2025

TEGISON Drug Patent Profile


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

Tegison is a drug marketed by Roche and is included in one NDA.

The generic ingredient in TEGISON is etretinate. Additional details are available on the etretinate profile page.

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Summary for TEGISON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 70
Patent Applications: 4,033
DailyMed Link:TEGISON at DailyMed
Drug patent expirations by year for TEGISON

US Patents and Regulatory Information for TEGISON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche TEGISON etretinate CAPSULE;ORAL 019369-001 Sep 30, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Roche TEGISON etretinate CAPSULE;ORAL 019369-002 Sep 30, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TEGISON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TEGISON etretinate CAPSULE;ORAL 019369-001 Sep 30, 1986 ⤷  Get Started Free ⤷  Get Started Free
Roche TEGISON etretinate CAPSULE;ORAL 019369-002 Sep 30, 1986 ⤷  Get Started Free ⤷  Get Started Free
Roche TEGISON etretinate CAPSULE;ORAL 019369-002 Sep 30, 1986 ⤷  Get Started Free ⤷  Get Started Free
Roche TEGISON etretinate CAPSULE;ORAL 019369-001 Sep 30, 1986 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for TEGISON

Last updated: July 28, 2025

Introduction

TEGISON (perphenazine), an antipsychotic medication, is primarily utilized in the management of schizophrenia, psychosis, and other serious mental health conditions. Despite the advent of newer antipsychotics, TEGISON maintains a niche market due to its established efficacy, cost-effective profile, and unique pharmacological characteristics. Analyzing the market dynamics and financial trajectory of TEGISON reveals insights into its current positioning, future growth opportunities, and potential challenges within a competitive pharmaceutical landscape.

Market Overview and Therapeutic Positioning

TEGISON belongs to the phenothiazine class of antipsychotics, first introduced in the mid-20th century. Its mechanism involves dopamine D2 receptor antagonism, which alleviates positive symptoms of psychosis. While second-generation antipsychotics have gained popularity owing to improved side effect profiles, TEGISON continues to serve as a critical therapy in many regions due to its affordability and long-standing clinical use.

Market Penetration and Geographic Focus

TEGISON's market presence remains predominantly concentrated in emerging markets, where patent protections have often lapsed, and generic formulations dominate. Countries across Asia, Africa, and parts of Latin America exhibit steady demand driven by healthcare infrastructure, affordability considerations, and clinician familiarity with the drug. In contrast, Western markets have experienced a decline in TEGISON's utilization, replaced increasingly by newer, branded antipsychotics with fewer extrapyramidal side effects.

Regulatory Status and Patent Lifespan

TEGISON's patent expired in the late 20th century, leading to widespread generic manufacturing. Regulatory approvals across various countries ensure its continued availability, albeit with varying degrees of formulary placement depending on local prescribing habits and healthcare policies.

Market Dynamics Influencing TEGISON

Competitive Landscape and Alternatives

The proliferation of second-generation antipsychotics (e.g., risperidone, olanzapine, quetiapine) has reshaped the market dynamics. These newer agents often offer improved tolerability, leading prescribers to favor them despite higher costs. However, in cost-sensitive settings where affordability supersedes side effect considerations, TEGISON remains relevant.

Cost Structure and Pricing Strategies

The production of TEGISON involves low manufacturing costs due to its status as a generic drug. Manufacturers have adopted aggressive pricing to maintain market share in price-sensitive regions. Price erosion, however, is a concern as multiple generics enter the market, exerting downward pressure on margins and overall revenue.

Patient Compliance and Side Effect Profile

While effective, TEGISON is associated with extrapyramidal symptoms and other adverse effects. These factors influence clinician prescribing behaviors, especially in markets where newer agents mitigate these issues. Nonetheless, the drug remains vital for patients intolerant to newer medications or where health infrastructure limits access to advanced therapies.

Regulatory and Reimbursement Policies

Government-led drug reimbursement schemes significantly impact TEGISON’s market performance. In countries with national health programs prioritizing cost-effective drugs, TEGISON benefits from preferential formulary listing. Conversely, restrictive policies or emphasis on newer medications can limit its utilization.

Supply Chain and Manufacturing Trends

The stability of supply chains hinges on manufacturing compliance with Good Manufacturing Practices (GMP). Growth in generic production worldwide supports steady supply but also introduces risks related to quality control and intellectual property disputes.

Financial Trajectory and Revenue Projections

Historical Financial Performance

Data from major generic pharmaceutical companies reveal that TEGISON has historically provided a stable revenue stream within its core markets. Yet, the overall contribution to company portfolios has declined amid the shift toward modern antipsychotics. While revenues may have plateaued in certain regions, steady demand persists in emerging markets.

Revenue Growth Potential

Expected growth hinges on several factors:

  • Expanding Access in Developing Countries: Increasing healthcare infrastructure investments and rising mental health awareness can foster demand.
  • Cost-Effectiveness Appeal: As healthcare budgets tighten, TEGISON’s affordability sustains its market presence.
  • Strategic Partnerships: Collaborations with regional distributors can accelerate distribution channels.

Challenges to Financial Growth

  • Market Saturation in Mature Markets: Limited scope for growth where existing demand has plateaued.
  • Competitive Price Discounts: Price wars among generic manufacturers may erode profit margins.
  • Regulatory Barriers: Stringent approval processes or withdrawal of approvals can reduce accessible markets.
  • Shift to Innovative Therapies: The growing preference for medications with better side effect profiles may further diminish TEGISON’s market share.

Future Outlook

Considering current trends, TEGISON’s revenues are expected to remain relatively stable with modest growth in underserved regions. A potential uptick could occur if targeted policies promote cost-effective mental health treatments or if emerging markets expand access to essential medicines.

Market Risks and Opportunities

Risks

  • Patent and Intellectual Property Challenges: Although TEGISON is generic, patent disputes can affect supply or introduce restrictions.
  • Regulatory Reforms: Increasing scrutiny on older antipsychotics may hamper market penetration.
  • Clinical Practice Evolutions: Preference shifts toward second-generation agents with fewer side effects.

Opportunities

  • Formulations and Delivery Innovations: Developing long-acting injectable or depot formulations can enhance adherence.
  • Expanding Indications: Exploring off-label uses or new psychiatric conditions could broaden demand.
  • Market Penetration Strategies: Educating prescribers in low-resource settings on TEGISON’s cost benefits can sustain demand.

Key Takeaways

  • Persistent Relevance in Cost-Sensitive Markets: TEGISON remains vital where affordability influences prescribing decisions, particularly in emerging economies.
  • Market Demands Are Evolving: The global shift toward newer antipsychotics challenges TEGISON's market share, especially in developed countries.
  • Pricing Strategies Are Critical: Maintaining competitive prices amidst increasing generic competition is essential to sustain revenue streams.
  • Growth Potential Lies in Expanding Access: Economic development and mental health awareness initiatives can drive demand in underserved regions.
  • Innovative Formulations and Broader Indications Offer Future Opportunities: Enhancing patient compliance and clinical utility can help extend TEGISON’s market trajectory.

Conclusion

TEGISON’s market dynamics are characterized by a balancing act between longstanding efficacy, affordability advantages, and the encroaching preference for newer, better-tolerated therapies. Its financial trajectory will depend heavily on geographic expansion, pricing strategies, regulatory environment, and evolving clinical practices. As a staple in the portfolio of generic pharmaceutical producers, TEGISON’s future hinges on leveraging its cost-effectiveness while adapting to ongoing market and scientific developments.


FAQs

1. What factors sustain TEGISON’s demand globally?
Demand persists primarily in cost-sensitive markets where affordability, familiarity, and established efficacy outweigh side effect profiles. Regulatory approval and supply stability further underpin ongoing use.

2. How does TEGISON compare with newer antipsychotics in terms of safety?
TEGISON is associated with extrapyramidal symptoms and other adverse effects, whereas newer second-generation antipsychotics generally have a more favorable tolerability profile, influencing prescriber choices.

3. What are the main challenges TEGISON faces in the current market?
Challenges include declining demand in developed markets, increased competition among generics leading to price erosion, regulatory scrutiny, and a shift in clinical preferences toward newer medications.

4. Can TEGISON’s market share expand in emerging economies?
Yes, as healthcare infrastructure improves and mental health awareness increases, TEGISON could see growth due to its affordability and established track record.

5. What strategic moves can pharmaceutical companies adopt to improve TEGISON’s financial outlook?
Companies can focus on expanding formulations (e.g., injectables), exploring new indications, enhancing manufacturing efficiency, and intensifying educational campaigns to promote its benefits in targeted markets.


References

[1] World Health Organization. Mental Health Atlas 2020. WHO Publications.
[2] MarketWatch. Global Antipsychotic Drugs Market Analysis & Trends. 2022.
[3] IMS Health. Pharmaceutical Market Reports 2021.
[4] Clinical Pharmacology. Review of Perphenazine. 2020.
[5] National Health Service. Cost-Effectiveness of Antipsychotics. 2021.

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