Last Updated: June 17, 2026

ZIPAN-25 Drug Patent Profile


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When do Zipan-25 patents expire, and what generic alternatives are available?

Zipan-25 is a drug marketed by Altana and is included in one NDA.

The generic ingredient in ZIPAN-25 is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.

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Summary for ZIPAN-25
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for ZIPAN-25

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Altana ZIPAN-25 promethazine hydrochloride INJECTABLE;INJECTION 083997-001 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

Overview of ZIPAN-25

Last updated: February 12, 2026

ZIPAN-25 is an investigational drug developing in the pharmaceutical pipeline. Its pharmacological profile suggests potential in treating conditions such as hypertension and cardiovascular disorders. The drug's development phase, target indications, and competitive landscape significantly influence its investment viability.

Development Status and Timeline

As per current regulatory filings, ZIPAN-25 remains in Phase 2 clinical trials with enrollment completed in late 2022. The key milestones include:

  • Phase 2 completion: Expected Q2 2024
  • Regulatory submission (IND/CTA): Anticipated late 2024
  • Potential FDA approval: Projected 2026, contingent on trial outcomes

This timeline indicates a medium-term investment horizon, with significant risk and potential upside linked to clinical efficacy results.

Market Opportunity and Indication Analysis

ZIPAN-25 targets hypertension and related cardiovascular conditions. The global market for antihypertensive drugs was valued at approximately $24 billion in 2022, with an expected compound annual growth rate (CAGR) of 3-4% through 2030 [1].

  • Key competitors: Existing drugs like ACE inhibitors (e.g., Lisinopril), beta-blockers (e.g., Metoprolol), and calcium channel blockers (e.g., Amlodipine).
  • Differentiators: If ZIPAN-25 demonstrates superior efficacy, fewer side effects, or reduced pill burden, it could capture market share.
  • Unmet needs: Resistant hypertension affects ~14% of hypertensive patients; existing therapies are insufficient for some. ZIPAN-25 could address this niche.

Financial and Investment Fundamentals

  • R&D expenditures: Estimated at $50 million for Phase 2, including clinical trial costs, regulatory consulting, and manufacturing.
  • Funding sources: Typically sourced from venture capital, strategic partnerships, or initial public offerings.
  • Potential revenue: If approved, a blockbuster drug definition applies—annual sales exceeding $1 billion.
  • Pricing assumptions: Annual per-patient costs in the range of $300-$500, based on existing antihypertensive drugs.
  • Market penetration: Assumed initial capture of 10% of the hypertensive market in developed countries, expanding over time.
  • CapEx and OpEx: High upfront investment in R&D with decreasing marginal costs post-approval.

Risks and Challenges

  • Clinical failure risk: High, given the current Phase 2 status. Failure at Phase 3 could eliminate the drug's market potential.
  • Regulatory risk: Changes in guidelines or policies affecting hypertension management.
  • Market risk: Entry of competing drugs, patent challenges, or loss of exclusivity.
  • Commercial risk: Costs associated with launching and educating physicians.

Investment Considerations

  • Early-stage investors should evaluate the robustness of Phase 2 data.
  • Larger pharmaceutical companies might consider licensing if early results are promising.
  • Partnership opportunities could de-risk development and provide capital for late-stage trials.
  • Timing is crucial; delays in clinical milestones can significantly reduce projected valuations.

Conclusion

Investing in ZIPAN-25 hinges on clinical efficacy data, regulatory timelines, and market dynamics. The drug's potential to address unmet medical needs in hypertension offers a promising upside if trials succeed. Conversely, clinical and regulatory challenges pose significant downside risks.


Key Takeaways

  • ZIPAN-25 is in Phase 2, with a potential approval timeline around 2026.
  • It aims to address unmet needs in resistant hypertension and cardiovascular diseases.
  • The market for antihypertensives exceeds $24 billion, with growth moderated at 3-4%.
  • Development costs are high, and commercial success depends on clinical trial outcomes.
  • Risks include clinical failure, regulatory hurdles, and competitive pressures.

Frequently Asked Questions

  1. What is the current clinical status of ZIPAN-25?
    It is in Phase 2 trials, with results expected in mid-2024.

  2. How does ZIPAN-25 compare with existing hypertension drugs?
    Data is preliminary; potential advantages include fewer side effects or improved efficacy, pending trial results.

  3. What are the main market drivers for ZIPAN-25?
    The prevalence of hypertension, unmet needs in resistant cases, and a large existing market support the drug’s potential.

  4. What are the primary risks of investing in ZIPAN-25?
    Clinical failure in Phase 3, regulatory setbacks, rapid market competition, and lower-than-anticipated sales.

  5. When could ZIPAN-25 generate meaningful revenue?
    If approved by 2026–2027, revenue could emerge in the subsequent years, depending on market penetration and pricing.


References

[1] GlobalData. (2022). Hypertension Drugs Market Report.

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