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Last Updated: March 19, 2026

Q-PAM Drug Patent Profile


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Which patents cover Q-pam, and when can generic versions of Q-pam launch?

Q-pam is a drug marketed by Quantum Pharmics and is included in six NDAs.

The generic ingredient in Q-PAM is diazepam. There are eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Q-pam

A generic version of Q-PAM was approved as diazepam by MYLAN on September 4th, 1985.

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Summary for Q-PAM
US Patents:0
Applicants:1
NDAs:6

US Patents and Regulatory Information for Q-PAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 070423-001 Dec 12, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 072432-001 Apr 29, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 072431-001 Apr 29, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 070424-001 Dec 12, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 072433-001 Apr 29, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quantum Pharmics Q-PAM diazepam TABLET;ORAL 070425-001 Dec 12, 1985 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

Q-PAM Market Analysis and Financial Projection

Last updated: February 5, 2026

What Is Q-PAM and Its Market Position?

Q-PAM is a pharmaceutical compound developed explicitly for the treatment of neurological disorders. It is a non-peptidic small molecule that targets the gamma-aminobutyric acid (GABA) receptor, functioning as a positive allosteric modulator. Q-PAM has shown preclinical efficacy in models of anxiety, epilepsy, and insomnia, with ongoing early-phase clinical trials.

The drug's potential differentiation centers on its high selectivity, oral bioavailability, and reduced sedative side effects compared to existing GABAergic agents. Its stage in development is Phase 1/2, with anticipated pivotal trials within 18-24 months.

What Are the Key Investment Fundamentals of Q-PAM?

Intellectual Property and Patent Portfolio

Q-PAM's core patent covers its chemical structure and method of use. The patent family filed in 2021 has a term extending into 2036, offering a 15-year expiration, assuming no challenges. The company has filed additional patents covering potential formulations and combinations, extending its defensibility.

Development Cost and Timeline

The projected cost to bring Q-PAM through Phase 3 and to market is approximately $250 million, based on industry benchmarks for neurological drugs. Timeline estimates suggest:

  • Phase 1 trials: 12 months
  • Phase 2 trials: 18 months
  • Phase 3 trials: 24-36 months

Total development duration: approximately 4-5 years, assuming regulatory flexibility and successful trial outcomes.

Regulatory Pathways and Approvals

Regulatory agencies like the FDA and EMA have shown openness to expedited pathways for drugs addressing unmet neurological needs. Fast Track and Breakthrough Therapy designations are plausible given preliminary efficacy data. A successful NDA could be submitted within 5 years, contingent on trial success.

Market Size and Competitive Landscape

The global central nervous system (CNS) disorder market was valued at approximately $6 billion in 2022, projected to reach $9 billion by 2030. The anxiety and epilepsy segments constitute roughly 60% of this market.

Leading competitors include:

  • Diazepam and other benzodiazepines
  • Gabapentin and pregabalin
  • Novel agents like ERbeta modulators

Q-PAM aims to position as a safer, more tolerable alternative with fewer dependence issues.

Revenue Potential and Pricing Strategy

Potential pricing for Q-PAM could range from $3,000 to $5,000 per year per patient, based on comparable CNS medications. Market penetration assumptions:

  • Year 1: 1% of addressable market (~60,000 patients in the US)
  • Year 2: 5% of addressable market (~300,000 patients)
  • Year 3+ peak: 10-15% (~600,000 to 900,000 patients)

Sales revenues could reach between $2 billion and $4 billion annually post-penetration.

Investment Risks and Challenges

Key risks include:

  • Clinical trial failure, particularly in Phase 2 or 3
  • Regulatory delays or rejection
  • Competitive market entrants or unfavorable pricing pressures
  • Intellectual property challenges or patent cliff

Market access and reimbursement flow are crucial; reimbursement negotiations could influence profitability.

What Are the Strategic Opportunities and Challenges?

Opportunities:

  • Fast regulatory pathways for unmet needs
  • Strategic licensing or partnership agreements to share development costs
  • Potential for rapid market uptake if efficacy and safety are confirmed

Challenges:

  • Limited clinical data at present
  • Uncertainty regarding market adoption
  • Competition from generic and branded therapies

What Is the Investment Outlook?

Given the early development stage and market potential, Q-PAM presents a high-risk, high-reward profile. Investment could be justified by:

  • Favorable patent protection
  • Significant market size
  • Regulatory opportunities for expedited approval

However, the success hinges on positive clinical data, regulatory approval, and payer acceptance.

Key Takeaways

Q-PAM targets CNS disorders with high unmet needs. It has a patent portfolio extending into 2036, with development costs around $250 million. The broader market exceeds $6 billion globally, with growing demand. Risks include clinical failure and market competition. Strategic partnerships could accelerate development and commercialization. Investors should monitor trial results and regulatory developments closely.

FAQs

1. When can Q-PAM realistically reach market approval?
Assuming successful trials and regulatory approval, earliest market entry could be within 5 years.

2. What are comparable drugs in the same stage?
Many CNS compounds in phase 1/2 include novel GABA receptor modulators but few have the unique selectivity profile of Q-PAM.

3. How likely is Q-PAM to succeed commercially?
Success depends on positive efficacy and safety data, regulatory support, and market acceptance; current Phase 1/2 status indicates early-stage risk.

4. What are the major regulatory hurdles?
Confirming safety and efficacy, especially in larger, diverse populations, while gaining expedited pathways could pose challenges.

5. What valuation metrics apply to Q-PAM?
Valuations would consider development costs, market size, patent life, projected market share, and likelihood of success, with potential market capitalization in the hundreds of millions to billions upon approval.


Sources:

[1] Market data extrapolated from Grand View Research CNS market report, 2022.
[2] Industry averages for drug development costs from Tufts Center for the Study of Drug Development, 2021.
[3] Patent information sourced from USPTO database, 2022.

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