Last Updated: June 17, 2026

STELAZINE Drug Patent Profile


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

Stelazine is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in STELAZINE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.

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Summary for STELAZINE
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for STELAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline STELAZINE trifluoperazine hydrochloride CONCENTRATE;ORAL 011552-006 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline STELAZINE trifluoperazine hydrochloride TABLET;ORAL 011552-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline STELAZINE trifluoperazine hydrochloride INJECTABLE;INJECTION 011552-005 Approved Prior to Jan 1, 1982 DISCN Yes 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
Last updated: February 3, 2026

What Is the Current Market and Investment Outlook for STELAZINE?

STELAZINE (perphenazine) is an antipsychotic medication primarily used to treat schizophrenia, psychosis, and nausea. The drug is off-patent, with generic versions widely available, and is not typically a driver of high-margin revenues. Its market size is modest, with sales driven primarily by existing institutional and generic distributors.

Despite its limited growth prospects, STELAZINE holds steady relevance in psychiatric and gastrointestinal indications, especially in regions with limited access to newer medications. Investment attractiveness hinges on the global demand for antipsychotics, regulatory stability, and any potential new indications or formulations that could alter its market dynamics.

What Are the Fundamentals of STELAZINE in Terms of R&D, Patents, and Regulatory Status?

STELAZINE is an established compound with a well-known pharmacological profile. Its patent protection expired decades ago, leading to generic manufacturing by multiple firms. Regulatory approval remains in place across major markets, including the United States, Europe, and parts of Asia.

R&D investment in STELAZINE itself appears minimal, focusing instead on new formulations or delivery systems. No recent major patent filings suggest active proprietary innovation. The drug's stability and affordability maintain its position in generic markets, especially where healthcare systems prioritize cost-effective treatments.

How Do Market Trends and Competitive Landscape Affect STELAZINE?

The antipsychotic market comprises first-generation drugs like STELAZINE and second-generation drugs such as risperidone and olanzapine. Second-generation drugs have gained favor due to improved side effect profiles, leading to a decline in first-generation antipsychotic use in developed countries.

However, in emerging markets, first-generation drugs remain prevalent due to lower costs and existing regulatory approval. The global antipsychotic market is expected to grow at about 3% annually, with the total market size reaching approximately USD 6.2 billion by 2025 [1].

STELAZINE's market share is declining in high-income regions but remains stable in lower-income and rural settings, which limits its growth potential but sustains steady revenues where it is used.

What Are the Risks and Opportunities for Investors?

Risks:

  • Shrinking market share in developed markets driven by newer medications.
  • Regulatory risks if agencies decide to phase out older drugs due to side effect concerns.
  • Competitive pressure from branded generics and new delivery formulations.

Opportunities:

  • Potential repositioning if new indications emerge or if combined with other therapies.
  • Market expansion in regions with limited access to newer drugs.
  • Development of improved formulations or formulations for special populations.

What Is the Investment Summary and Outlook?

STELAZINE's investment case is weak in markets favoring innovation and newer therapies. Its value lies mainly in its established, cost-effective profile for specific regional markets. Limited R&D and patent life suggest low growth potential but steady cash flow in existing markets.

Potential investors should monitor regulatory developments, regional market shifts, and indications for any new formulations that could translate into marginal upside.

Key Takeaways

  • STELAZINE is an off-patent, generic antipsychotic with a stable but limited market.
  • Its core markets include regions where cost considerations favor older first-generation drugs.
  • Market decline in high-income regions contrasts with steady demand in lower-income zones.
  • Innovations are minimal; the drug's future depends on regional demand and price competition.
  • Investment prospects are modest, mainly reflecting steady cash flows rather than growth opportunities.

FAQs

1. Is STELAZINE still under patent protection?
No. Its patent has expired, facilitating generic competition worldwide.

2. What are the main regions where STELAZINE remains relevant?
Primarily in lower-income countries and rural regions in high-income countries with limited access to newer antipsychotics.

3. Are there any ongoing clinical trials or new formulations for STELAZINE?
No significant clinical trials or new formulations have been announced recently.

4. What impact could regulatory changes have on STELAZINE's market?
Stricter safety regulations for first-generation antipsychotics could reduce its usage, especially if side effects are re-evaluated.

5. How does the competitive landscape compare?
It faces stiff competition from second-generation antipsychotics, which are preferred in many markets due to better tolerability.


References:

[1] IQVIA, "Global Psychiatry Market Outlook," 2022.

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