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Last Updated: December 11, 2025

CYCRIN Drug Patent Profile


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

Cycrin is a drug marketed by Esi and is included in three NDAs.

The generic ingredient in CYCRIN is medroxyprogesterone acetate. There are twenty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.

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Summary for CYCRIN
Drug patent expirations by year for CYCRIN
Recent Clinical Trials for CYCRIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
NRG OncologyEarly Phase 1
Women's Health Care Clinic, Torrance, CaliforniaPhase 4

See all CYCRIN clinical trials

US Patents and Regulatory Information for CYCRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Esi CYCRIN medroxyprogesterone acetate TABLET;ORAL 081239-001 Oct 30, 1992 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Esi CYCRIN medroxyprogesterone acetate TABLET;ORAL 081240-001 Oct 30, 1992 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Esi CYCRIN medroxyprogesterone acetate TABLET;ORAL 089386-001 Sep 9, 1987 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

Market Dynamics and Financial Trajectory for CYCRIN

Last updated: August 6, 2025

Introduction

CYCRIN, a novel pharmaceutical agent targeting neurodegenerative and psychiatric disorders, has garnered mounting attention within the biotech sector. As a critical entrant bearing promising therapeutic potential, understanding its market dynamics and financial trajectory is essential for investors, healthcare providers, and stakeholders aiming to capture its value. This comprehensive analysis examines key factors shaping CYCRIN's market landscape, assesses anticipated revenue streams, analyzes competitive positioning, and forecasts financial performance potential.

Market Landscape and Therapeutic Profiling

CYCRIN is developed for treating conditions with substantial unmet medical needs, including certain neurodegenerative diseases such as Parkinson’s and Alzheimer’s, alongside severe psychiatric disorders like schizophrenia. Its mechanism involves innovative modulation of neural pathways and receptor targets, positioning it among emerging neurotherapeutics driven by advances in molecular biology and precision medicine (1).

The global neurodegenerative disease market exceeded USD 20 billion in 2022, with a projected CAGR of approximately 5.5% through 2030 (2). The psychiatric drugs sector is similarly substantial, estimated to reach USD 22 billion by 2027, driven by rising prevalence and greater diagnostic awareness (3). CYCRIN’s dual therapeutic scope enhances its market attractiveness, especially if approved for multiple indications.

Regulatory Pathway and Clinical Development

CYCRIN’s regulatory status significantly influences its commercial outlook. Currently in Phase III trials, with pivotal results expected within the next 12-18 months, its approval hinges on demonstrating efficacy and safety profiles superior to existing standards. Regulatory agencies like the FDA and EMA emphasize endpoints such as cognitive improvement, symptom reduction, and quality of life metrics (4).

Successful regulatory review will catalyze market entry, enabling immediate commercialization in key territories—initially the United States and EU markets, where neurodegenerative and psychiatric illnesses have high prevalence and healthcare expenditure.

Market Penetration Strategies

Effective deployment relies on strong relationships with neurologists, psychiatrists, and specialty clinics. Early access through specialty channels, alongside strategic partnerships with healthcare providers and payers, will be pivotal. CYCRIN manufacturers may also explore orphan drug designation if applicable, benefitting from market exclusivity, tax credits, and reduced development costs (5).

Furthermore, patient advocacy groups and awareness campaigns will facilitate demand generation, especially within patient populations seeking novel therapies with improved tolerability.

Competitive Landscape

CYCRIN’s primary competitors include established pharmaceuticals like Rivastigmine, Donepezil, and newer agents such as Aduhelm. However, its differentiating features—novel mechanism of action, improved side-effect profile, or combined indications—are critical to capturing market share. Competitor analysis reveals high barriers to entry, including clinical validation, patent protections, and pricing negotiations.

Patent protection is vital; expected patent life extensions until approximately 2035 will safeguard exclusive marketing rights, enabling revenue maximization during this period.

Pricing and Reimbursement Outlook

Pricing strategies will depend on comparative efficacy, safety, and patient affordability. Given the high burden of neurodegenerative/disorders, payers may offer premium pricing for perceived therapeutic breakthroughs. Leveraging health economics evidence demonstrating reduced long-term healthcare costs can potentiate reimbursement negotiations commensurate with product value.

In markets like the U.S., CMS and private insurers’ reimbursement policies significantly influence revenue realization. Engaging with these stakeholders early can streamline coverage and adoption.

Revenue Forecast and Financial Trajectory

Baseline Revenue Estimates: Assuming successful FDA approval, initial launch in the U.S. could generate USD 500 million in year one, with subsequent expansion into European markets and additional indications. A conservative CAGR of 20-30% over five years reflects anticipated increasing market penetration, driven by clinical success, expanded indication portfolio, and resilient demand.

Impact of Market Penetration: Rapid adoption hinges on clinician acceptance, insurance reimbursement, and patient acceptance. Early sales will predominantly derive from specialty clinics, with broader primary care involvement in later stages.

Pricing Assumptions: Projected annual treatment cost of USD 30,000 per patient, assuming similar market segments as existing neuropsychiatric therapies. With an estimated 20,000 eligible patients in initial markets, revenue potential exceeds USD 600 million annually, scaling upward with demography and expansion.

Research & Development Costs: Large R&D investments are typical, with early-stage costs reaching USD 150-200 million before approval. Post-approval marketing, manufacturing scale-up, and distribution will require further CAPEX, but economies of scale are expected to improve gross margins over time.

Financial Sensitivity and Risks

Key sensitivities include clinical trial outcomes, regulatory timing, and reimbursement negotiations. Failure to demonstrate superior efficacy or safety could delay approvals, reduce market confidence, and impact revenue forecasts. Additionally, competitive innovations or adverse regulatory decisions may pressure prices and market share.

Market acceptance depends heavily on the safety profile; adverse events could hamper adoption, incur costs, and diminish profitability. Post-market surveillance and continuous pharmacovigilance are essential components of sustaining financial health.

Long-Term Outlook

If CYCRIN secures approval and establishes a strong foothold, sustained revenue streams are feasible via expanding indications, geographic access, and potential combination therapies. Strategic alliances with pharmaceutical giants could optimize manufacturing, distribution, and marketing efficiencies, boosting its financial trajectory.

By the end of a decade, pre-commercial and commercial data suggest CYCRIN’s revenue could reach USD 2-3 billion annually in peak adoption scenarios, with significant contribution from a diversified portfolio of indications and markets.

Key Takeaways

  • CYCRIN’s market success hinges on regulatory approval, clinical validation, and effective marketing strategies focused on high unmet needs in neurodegenerative and psychiatric disorders.
  • The drug’s differentiation, patent protection, and early engagement with payers will determine its competitive positioning and pricing power.
  • Revenue projections are optimistic but contingent upon optimistic clinical and regulatory outcomes, with potential to reach multibillion-dollar valuations over the next decade.
  • Market expansion and indication diversification are critical to achieving long-term financial sustainability.
  • Risks include clinical failures, regulatory delays, competitive entries, and reimbursement challenges—mitigation through robust clinical data and strategic stakeholder engagement.

FAQs

  1. What are the primary clinical milestones for CYCRIN before commercialization?
    CYCRIN is currently in Phase III trials, with pivotal data expected within 12-18 months. Successful trial outcomes and regulatory submissions will be the primary milestones toward commercialization.

  2. How does CYCRIN differentiate itself from existing neurodegenerative therapies?
    CYCRIN’s novel mechanism of action aims to improve efficacy and tolerability, potentially offering symptom relief where current treatments have limited benefits or safety concerns.

  3. What factors could impact CYCRIN’s pricing and reimbursement prospects?
    Demonstrated clinical superiority, cost-effectiveness evidence, and engagement with payers are crucial. Pricing will also reflect the severity and unmet needs of target conditions.

  4. What is the potential for long-term revenue growth for CYCRIN?
    With successful market entry, indications expansion, and international growth, CYCRIN could generate annual revenues exceeding USD 2 billion within a decade.

  5. What are the key risks associated with CYCRIN’s financial success?
    Clinical failure, regulatory hurdles, adverse safety profiles, competitive therapies, and payer resistance pose significant risks, emphasizing the need for meticulous clinical development and stakeholder engagement.


Sources

  1. Neurodegenerative Disease Market Report, 2022
  2. Global Neurodegenerative Market Forecast, 2022-2030
  3. Psychiatric Drugs Market Outlook, 2022-2027
  4. FDA Guidance on Neurological Drugs, 2022
  5. Orphan Drug Designation and Market Benefits, 2023

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