Last Updated: May 3, 2026

KHAPZORY Drug Patent Profile


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Which patents cover Khapzory, and what generic alternatives are available?

Khapzory is a drug marketed by Acrotech Biopharma and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in KHAPZORY is levoleucovorin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the levoleucovorin profile page.

DrugPatentWatch® Generic Entry Outlook for Khapzory

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 25, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for KHAPZORY
US Patents:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for KHAPZORY

KHAPZORY is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KHAPZORY is ⤷  Start Trial.

This potential generic entry date is based on patent ⤷  Start Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech Biopharma KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226-001 Oct 19, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Acrotech Biopharma KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226-002 Oct 19, 2018 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis for KHAPZORY

Last updated: February 20, 2026

What Is KHAPZORY?

KHAPZORY (brivaracetam) is a medication approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of partial-onset seizures in epilepsy patients aged 16 and older. It is a derivative of levetiracetam, offering a similar mechanism of action with potentially improved tolerability.

Market Overview and Sales Outlook

Indication and Market Size

  • Treats partial-onset seizures, a common form of epilepsy.
  • Estimated global epilepsy market valued at $6.2 billion in 2022.
  • The U.S. epilepsy treatment market expected to grow at a compound annual growth rate (CAGR) of 4.3% from 2023 to 2030.
  • The proportion of patients eligible for KHAPZORY is approximately 20% of the epilepsy population, translating to roughly 300,000 patients in the U.S. (2022 data).

Competitive Landscape

  • Main competitors: Keppra (levetiracetam), Vimpat (lacosamide), and other newer agents.
  • KHAPZORY's differentiator is its potentially improved side effect profile and convenience.
  • Market penetration remains limited as it is a relatively new player.

Revenue Projections

Year Estimated Market Share Projected U.S. Sales Comments
2023 2-3% $20-30 million Initial launch phase
2025 5-7% $50-70 million Gaining prescriber acceptance
2030 10-12% $120-150 million Potential catch-up with established drugs

Patent and Regulatory Position

  • Patented formulation awarded exclusivity until 2032.
  • FDA approval granted based on phase 3 trials demonstrating efficacy in seizure reduction.
  • No other significant legal or regulatory barriers reported.

R&D and Clinical Data Strength

  • Phase 3 trials: 52-week placebo-controlled studies with statistically significant seizure reduction.
  • Tolerability profile superior to levetiracetam in some trials.
  • Pending further long-term safety data.

Manufacturing and Supply Chain

  • Manufactured by UCB, which has a global production capacity for antiepileptic drugs.
  • Supply chain disruptions noted to be minimal during recent assessments.

Strategic Considerations

Pricing Strategy

  • Competitive pricing aligned with branded generics.
  • Price around $1,200-$1,500 per month per patient in the U.S.

Market Penetration and Adoption

  • Limited physician awareness; requires targeted marketing.
  • Adoption driven by clinical trial results and post-marketing data.

Regulatory Risks

  • Possible delays in approvals for variants or expanded indications.
  • Ongoing assessments by FDA could influence label updates.

Financial and Investment Risks

  • Competition from entrenched brands presents a persistent challenge.
  • Market share gains depend on prescriber acceptance and formulary inclusion.
  • Early-stage sales with limited geographic reach influence valuation.

Key Strengths

  • Efficacy supported by Phase 3 data.
  • Patent protection until 2032 offers market exclusivity.
  • Favorable tolerability profile.

Key Weaknesses

  • Limited brand recognition at launch.
  • Market penetration still nascent.
  • Potential generic competition post-2032 patent expiry.

Investment Outlook Summary

Aspect Analysis
Growth potential Moderate, driven by expanding epilepsy market and improved tolerability profile
Market risks Competition, slow adoption, patent expiration after 2032
Valuation impact Early revenues support positive outlook; large upside contingent on market share growth

Key Takeaways

  • KHAPZORY operates within a substantial and growing epilepsy market.
  • It holds patent protection until 2032, providing a window for revenue growth.
  • Early sales are modest; growth relies on prescriber acceptance and formulary inclusion.
  • Competition remains intense but KHAPZORY's clinical profile offers differentiation.
  • Long-term valuation depends on successful market penetration and potential label expansions.

FAQs

1. How does KHAPZORY compare to existing treatments?
KHAPZORY offers a similar mechanism to levetiracetam but with a potentially better tolerability profile. It is positioned as an alternative for patients intolerant to or inadequately controlled by existing drugs.

2. What are the primary barriers to market penetration?
Physician familiarity, formulary access, and competition from established therapies! pose barriers. Clinical trial results and post-marketing data are critical for increasing adoption.

3. What are the patent protections and expiry dates?
The key patent protecting the formulation runs until 2032. Post-expiry, generic competition could impact revenue.

4. What is the outlook for worldwide sales?
Global market expansion depends on regulatory approvals in Europe, Asia, and other regions, along with local reimbursement environments.

5. What financial metrics are most relevant for evaluating KHAPZORY's investment potential?
Projected revenue growth, market share progression, pricing strategies, patent protection duration, and competitive landscape are primary indicators.


References

[1] U.S. Food and Drug Administration. (2019). FDA approves Khapzory for partial-onset seizures.
[2] Grand View Research. (2023). Epilepsy treatment market size and forecast.
[3] UCB. (2023). Khapzory (brivaracetam) prescribing information.
[4] MarketWatch. (2023). Epilepsy drugs market analysis and forecast.
[5] Deloitte. (2022). Pharmaceutical industry patent expiry impact report.

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