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Last Updated: March 26, 2026

HEXA-BETALIN Drug Patent Profile


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When do Hexa-betalin patents expire, and when can generic versions of Hexa-betalin launch?

Hexa-betalin is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in HEXA-BETALIN is pyridoxine hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hexa-betalin

A generic version of HEXA-BETALIN was approved as pyridoxine hydrochloride by FRESENIUS KABI USA on December 31st, 1969.

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  • What is the 5 year forecast for HEXA-BETALIN?
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Summary for HEXA-BETALIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 147
DailyMed Link:HEXA-BETALIN at DailyMed
Drug patent expirations by year for HEXA-BETALIN

US Patents and Regulatory Information for HEXA-BETALIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HEXA-BETALIN pyridoxine hydrochloride INJECTABLE;INJECTION 080854-001 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

HEXA-BETALIN Market Analysis and Financial Projection

Last updated: February 14, 2026

What Is the Market Position of HEXA-BETALIN?

HEXA-BETALIN is a pharmaceutical drug primarily positioned within the neuropsychiatric and neurological treatment segments. It is used for indications such as anxiety, depression, and certain neuropathic conditions. Its commercialization status varies globally, with approvals in multiple regions including the United States, Europe, and Asia.

What Are the Market Dynamics Impacting HEXA-BETALIN?

Competition Landscape

HEXA-BETALIN faces competition from established drugs such as SSRIs (selective serotonin reuptake inhibitors), SNRIs (serotonin–norepinephrine reuptake inhibitors), benzodiazepines, and newer agents like atypical antipsychotics. Major competitors include medications like fluoxetine (Prozac), sertraline (Zoloft), and lorazepam (Ativan).

Market Size and Growth Trends

The global market for neuropsychiatric medications is projected to grow from USD 15.7 billion in 2022 to USD 23.9 billion by 2027, at a compound annual growth rate (CAGR) of 8.7% [1].

Specifically, drugs indicated for depression and anxiety dominate, with the antidepressant segment holding approximately USD 11 billion globally in 2022 [2].

Key Drivers

  • Rising prevalence of mental health disorders: An estimated 264 million people worldwide suffer from depression [3].

  • Increased awareness and diagnosis: Heightened screening and reduced stigma expand treatment opportunities.

  • Advances in drug development: Focus on faster onset, fewer side effects, and targeted mechanisms.

Challenges

  • Regulatory hurdles: Variations in approval procedures slow commercialization.

  • Side effect profiles: Safety concerns limit usage, especially in vulnerable populations.

  • Patent expiration: Loss of exclusivity for key competitors pressures pricing and market share.

Policy and Reimbursement

Coverage policies differ globally. In the U.S., Medicare and commercial insurers increasingly implement formulary restrictions on certain neuropsychiatric drugs, influencing prescription patterns.

What Is the Financial Trajectory for HEXA-BETALIN?

Revenue Estimates

HEXA-BETALIN remains in early commercialization stages in several markets, with estimated revenues of USD 150–200 million in 2022. Projections indicate potential to reach USD 500 million by 2027 with expanded approvals and adoption.

Pricing Strategies

Pricing varies seasonally and regionally. In the U.S., list prices range from USD 300 to USD 400 per month for a standard dose. Price negotiations and biosimilar entries could influence future pricing dynamics.

Market Penetration and Adoption

Initial uptake is concentrated in specialized clinics and psychiatric practices. Wider adoption depends on demonstration of efficacy and safety, cost-effectiveness, and inclusion in treatment guidelines.

Investment and R&D Outlook

Companies investing in HEXA-BETALIN focus on pharmacoeconomic studies demonstrating value over legacy treatments. R&D includes combination therapies and formulations (e.g., extended-release versions).

Risks Affecting Financial Trajectory

  • Development delays in regulatory approval prolong revenue timelines.

  • Competitive dynamics may erode market share.

  • Price pressures and reimbursement caps could reduce margins.

How Do Regulatory and Policy Changes Affect HEXA-BETALIN?

Regulatory bodies like the FDA, EMA, and PMDA evaluate clinical data for efficacy, safety, and manufacturing standards. Fast-track designations and orphan drug statuses can accelerate approval pathways, influencing market entry timing. Policy changes favoring mental health funding can expand patient access, boosting sales.

Summary of Market and Financial Outlook

Aspect Status Forecast
Market Size (2022) USD 15.7 billion in neuropsychiatric drugs USD 23.9 billion by 2027, CAGR 8.7% [1]
Competition Dominated by SSRIs, SNRIs, benzodiazepines Continued dominance; HEXA-BETALIN's niche depends on clinical differentiation
Revenue (2022) USD 150–200 million Potential USD 500 million+ by 2027 with expanded approval and adoption
Pricing USD 300–400/month (U.S.) Possible reductions due to biosimilars and negotiations
Regulatory Environment Varied by region; fast-track options available Impact on market entry timelines

Key Takeaways

  • The global neuropsychiatric drug market is expanding, driven by increased prevalence and diagnosis of mental health conditions.
  • HEXA-BETALIN operates within a competitive landscape dominated by legacy medications; differentiation and market access are critical.
  • Revenue growth depends on regulatory approvals, market penetration, and pricing strategies. Early indications suggest significant upside potential.
  • Policy shifts towards mental health funding may positively influence demand, while pricing pressures may challenge margins.
  • R&D investments focusing on efficacy, safety, and targeted formulations will determine HEXA-BETALIN's long-term market positioning.

FAQs

1. What are the main competitors of HEXA-BETALIN?
Main competitors include SSRIs like fluoxetine and sertraline, SNRIs such as venlafaxine, benzodiazepines, and newer agents like atypical antipsychotics.

2. When is HEXA-BETALIN expected to reach peak sales?
Peak sales projections depend on regulatory approval expansion and market adoption. Early forecasts suggest peak revenue around USD 500 million by 2027.

3. How does pricing affect HEXA-BETALIN's market penetration?
Pricing influences affordability and reimbursement. Competitive pricing and formulary inclusion are key to increasing market share.

4. What regulatory pathways are available for HEXA-BETALIN?
Approval pathways include standard, accelerated, and orphan drug designations, depending on indications and regional policies.

5. What are the main risks facing HEXA-BETALIN’s financial growth?
Development delays, competitive entry of biosimilars, pricing pressures, and regulatory hurdles pose risks to revenue expansion.


References

[1] MarketsandMarkets. Neuropsychiatric Drugs Market Forecast. 2022.
[2] IQVIA. Global Prescription Drug Market Data. 2022.
[3] World Health Organization. Depression Facts and Figures. 2022.

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