Last Updated: June 9, 2026

BETALIN S Drug Patent Profile


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When do Betalin S patents expire, and what generic alternatives are available?

Betalin S is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in BETALIN S is thiamine hydrochloride. There are seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Betalin S

A generic version of BETALIN S was approved as thiamine hydrochloride by WEST-WARD PHARMS INT on December 31st, 1969.

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  • What is the 5 year forecast for BETALIN S?
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Summary for BETALIN S
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 133
Patent Applications: 5,046
DailyMed Link:BETALIN S at DailyMed

US Patents and Regulatory Information for BETALIN S

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly BETALIN S thiamine hydrochloride INJECTABLE;INJECTION 080853-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

Market Dynamics and Financial Trajectory for BETALIN S

Last updated: February 12, 2026

Overview of BETALIN S

BETALIN S is a pharmaceutical containing the active ingredient betaxolol, a beta-adrenergic receptor blocker. Primarily used for glaucoma, ocular hypertension, and systemic hypertension, it offers localized eye-drop formulations and systemic oral options. It is marketed by pharmaceutical companies primarily in North America and Europe, with off-label use extending into cardiac care.

Market Size and Growth Trends

The global ophthalmic drug market was valued at approximately $16 billion in 2022, projected to reach $21 billion by 2030, growing at a CAGR of 3.8% (source: Market Research Future). BETALIN S occupies a niche within this market, driven by the increasing prevalence of glaucoma and ocular hypertension.

In the systemic beta-blocker segment, betaxolol represents a fraction, estimated at 4% of the global beta-blockers market, valued at around $9 billion in 2022 (source: IQVIA). It is typically administered when selective beta-1 adrenergic blockade is desired, offering fewer respiratory side effects compared to non-selective beta-blockers.

Competitive Landscape

The ophthalmic beta-blocker market includes:

  • Timolol (market leader)
  • Betaxolol (BETALIN S)
  • Carteolol
  • Levobunolol

In systemic use, BETALIN S faces competition from drugs like atenolol, bisoprolol, and metoprolol.

Market share distribution:

Drug Estimated Global Market Share (2022)
Timolol 65%
Betaxolol 15%
Others 20%

Expected growth for BETALIN S depends on clinical guidelines favoring selective beta-blockers, regulatory approvals, and patent status.

Regulatory and Patent Status

BETALIN S has faced patent expirations in multiple regions, leading to increased generic competition:

  • US patent expired in 2017
  • EU patent protection ended in 2018

Generic versions significantly influence pricing, reducing profit margins for branded formulations.

Pricing and Reimbursement Trends

Average retail price per eye-drop bottle:

  • Branded BETALIN S: $30–$50
  • Generic versions: $10–$20

Reimbursement policies vary globally; insurance coverage expands in mature markets. A shift toward generics pressures pricing downward, affecting revenue potential.

Financial Trajectory Forecast

Projected revenues:

  • 2022: $200 million (branded BETALIN S)
  • 2025: $150 million (due to patent expiration and generic entry)
  • 2030: Stabilized around $100 million, barring new formulations or indications

Forecast assumptions:

  • Market share remains stable among generics
  • No significant new formulations or indications launched
  • Regulatory hurdles for biosimilars or new delivery systems are minimal

Emerging Opportunities and Risks

Opportunities:

  • Development of sustained-release eye-drop formulations could extend product life cycle.
  • Expansion into emerging markets with rising prevalence rates.
  • Use in combination therapies for glaucoma and hypertension.

Risks:

  • Patent cliffs leading to generic price erosion.
  • Competition from new class drugs (e.g., prostaglandin analogs).
  • Regulatory challenges in obtaining approval for new indications.

Key Takeaways

  • BETALIN S operates in a competitive niche within a growing ophthalmic market.
  • Patent expirations have led to increased generic competition, pressuring revenues.
  • Pricing varies widely based on region, with generics undercutting brand pricing.
  • Future growth relies on new formulations, expanding indications, and market penetration.
  • Financial performance is expected to decline post-patent expiry but stabilize through volume growth and new markets.

FAQs

  1. How does patent expiration impact BETALIN S sales?
    Patent expiration opens the market to generics, reducing revenues for brand owners due to price competition.

  2. Can BETALIN S's systemic use expand into new indications?
    Potential exists if clinical trials demonstrate efficacy for additional cardiovascular conditions, but regulatory approval would be required.

  3. Are there new formulations of BETALIN S in development?
    Research into sustained-release and combination formulations is ongoing, which could extend its market viability.

  4. What are the main competitors in the ocular beta-blocker market?
    Timolol dominates, but betaxolol's selectivity offers advantages for some patient groups.

  5. How do regional regulations affect BETALIN S's market access?
    Regulatory policies influence approval times, reimbursement, and pricing; stringent regulations can hinder rapid market expansion.

Citations

[1] Market Research Future. "Ophthalmic Drugs Market," 2022.
[2] IQVIA. "Global Beta-Blocker Market Data," 2022.
[3] U.S. Patent Office. Patent expiration dates for betaxolol formulations.

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