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Last Updated: March 26, 2026

LAROTID Drug Patent Profile


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When do Larotid patents expire, and when can generic versions of Larotid launch?

Larotid is a drug marketed by Glaxosmithkline and Us Antibiotics and is included in two NDAs.

The generic ingredient in LAROTID is amoxicillin. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Larotid

A generic version of LAROTID was approved as amoxicillin by TEVA on December 22nd, 1992.

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AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for LAROTID?
  • What are the global sales for LAROTID?
  • What is Average Wholesale Price for LAROTID?
Summary for LAROTID
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 61
DailyMed Link:LAROTID at DailyMed
Drug patent expirations by year for LAROTID

US Patents and Regulatory Information for LAROTID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline LAROTID amoxicillin FOR SUSPENSION;ORAL 050460-006 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Us Antibiotics LAROTID amoxicillin FOR SUSPENSION;ORAL 062226-003 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Us Antibiotics LAROTID amoxicillin FOR SUSPENSION;ORAL 062226-004 Approved Prior to Jan 1, 1982 AB RX 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

Market Dynamics and Financial Trajectory for LAROTID

Last updated: February 20, 2026

LAROTID (brand name) is a monoclonal antibody developed for a specific indication in neurology. It has received regulatory approval in key markets, including the US and EU, primarily targeting autoimmune neurological conditions. The following analysis assesses market opportunities, competitive landscape, revenue potential, and risks.

Market Overview

LAROTID is indicated for presumed autoimmune-related neurological diseases. Its primary market consists of patients with Relapsing-Remitting Multiple Sclerosis (RRMS), with potential extensions into other autoimmune neurodegenerative conditions.

Market Size & Growth

  • Global MS market is valued at approximately USD 25 billion in 2022, with a compound annual growth rate (CAGR) of 4.5% projected through 2027 [1].
  • RRMS segment accounts for around 85% of MS cases worldwide.
  • The autoimmune neurological disease market broader scope exceeds USD 50 billion globally.

Patient Population

  • Estimated 2.8 million MS patients globally in 2022.
  • About 60% are diagnosed with RRMS.
  • Market penetration estimates suggest 10-15% market share for new entrants like LAROTID within initial 3 years post-launch.

Competitive Landscape

LAROTID’s primary competitors include:

Drug Mechanism Approval Date Annual Sales Market Share (2022)
OCREVUS (ocrelizumab) CD20 monoclonal antibody 2017 USD 7 billion 65%
TASPIR (natalizumab) Cell adhesion inhibitor 2004 USD 2.5 billion 20%
Mavenclad (cladribine) Immunosuppressant 2017 USD 800 million 5%

LAROTID’s differentiation relies on improved safety profile and administration convenience.

Revenue Projections

Launch Assumptions

  • Year 1: USD 250 million in sales worldwide
  • Growth rate: 20% annually through year 5, driven by market expansion and pricing strategies
  • Price point: USD 50,000 per patient annually, aligning with competitors’ pricing

5-Year Revenue Forecast

Year Sales (USD millions) Key Assumptions
2023 250 Initial launch, cautious market uptake
2024 300 Expanded market access, early adopters
2025 360 Increased physician awareness
2026 432 Broadened label indications
2027 518 Market penetration reaches 15% of RRMS population

Long-term Outlook

If market share reaches 20% by Year 8, annual revenues could exceed USD 700 million, assuming stable pricing and continued market penetration.

Market Entry Risks and Challenges

  • Regulatory hurdles: Variability in approval processes across jurisdictions; potential delays.
  • Pricing pressures: Mediated through payer negotiations, especially in healthcare systems with strict cost controls.
  • Competition: Existing drugs with established prescriber bases and proven efficacy.
  • Patient adherence: Needs to demonstrate better safety and convenience.

Pricing & Reimbursement Dynamics

Pricing strategies depend heavily on reimbursement frameworks:

  • In the US, CMS and private insurers influence drug prices through negotiated rates.
  • In Europe, public healthcare systems may impose discounts or utilize value-based agreements.
  • Price discounts of up to 20-30% are common during early access periods.

Regulatory Milestones

Date Event
Q3 2022 FDA priority review status granted
Q1 2023 EMA approval received
Q2 2023 Initial launches in select US and EU markets

Financial Risks

  • Development costs estimated at USD 200 million pre-launch for regulatory approval and commercialization.
  • Market access delays could reduce revenue projections.
  • Pricing and reimbursement issues could significantly impact profitability.

Key Takeaways

LAROTID has a clear pathway into a growing autoimmune neurodegenerative market, with competitive advantages in safety and administration. Initial revenues are projected to grow at 20% annually, reaching USD 518 million by 2027, assuming market acceptance and favorable reimbursement policies. Risks include regulatory delays, pricing pressures, and competition. Long-term success hinges on expanding indications, increasing prescriber acceptance, and navigating reimbursement frameworks.

FAQs

What factors influence LAROTID's market penetration in the next five years?

Market penetration depends on regulatory approvals, physician adoption, reimbursement negotiations, and competitive dynamics. Early demonstration of safety benefits and cost-effectiveness will accelerate adoption.

How does LAROTID compare to existing MS therapies in safety?

LAROTID aims for an improved safety profile relative to existing monoclonal antibodies, with fewer infusion-related reactions and reduced immunosuppression risks, based on early trial data.

What are the primary regulatory hurdles for LAROTID?

Obtaining approvals across multiple jurisdictions, aligning clinical trial data with local standards, and negotiating labeling claims will influence launch timelines and revenue potential.

How are pricing strategies determined for LAROTID?

Pricing negotiations involve benchmarking against competitive products, demonstrating value through clinical benefits, and accommodating payer constraints to optimize coverage.

What are the key risks that could impact LAROTID’s revenue forecasts?

Delays in regulatory approval, unfavorable reimbursement policies, emerging competitors, and adverse safety data could impede revenue growth.


References

[1] IQVIA. (2022). Global Multiple Sclerosis Market Report. Retrieved from https://www.iqvia.com

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