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Last Updated: December 13, 2025

LO-TROL Drug Patent Profile


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Which patents cover Lo-trol, and what generic alternatives are available?

Lo-trol is a drug marketed by Vangard and is included in one NDA.

The generic ingredient in LO-TROL is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

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Summary for LO-TROL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 5
Patent Applications: 198
DailyMed Link:LO-TROL at DailyMed
Drug patent expirations by year for LO-TROL

US Patents and Regulatory Information for LO-TROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vangard LO-TROL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 088009-001 Mar 25, 1983 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 the Pharmaceutical Drug: LO-TROL

Last updated: July 30, 2025

Introduction

LO-TROL, a botulinum toxin-based therapeutic, has carved out a niche within neurology and aesthetic medicine markets. Its innovative mechanism of action and targeted indications position it uniquely in an evolving pharmaceutical landscape. Exploring its market dynamics and projecting its financial trajectory necessitates an understanding of its therapeutic profile, competitive positioning, regulatory environment, and broader industry trends.

Therapeutic Profile and Indications

LO-TROL is primarily indicated for conditions such as cervical dystonia, blepharospasm, chronic migraine, and certain urological disorders—applications aligned with botulinum toxin products [1]. The drug operates by inhibiting acetylcholine release at neuromuscular junctions, providing symptomatic relief with durable effects. Its efficacy and safety profile have been substantiated through multiple clinical trials, fostering clinician confidence.

Recent advancements have expanded its scope into aesthetic medicine, notably wrinkle reduction and facial rejuvenation, mirroring the strategy employed by competitors like Botox and Dysport [2]. This diversification enhances its market appeal, especially amid rising demand for minimally invasive cosmetic procedures.

Market Dynamics

Competitive Landscape

LO-TROL operates within a mature yet fiercely competitive segment of neuromodulators and botulinum toxin products. Major competitors include Allergan’s Botox, Dysport (Ipsen), and Xeomin (Evolus). Market share is heavily influenced by factors such as brand recognition, physician preference, pricing, and regulatory approvals [3].

A key dynamic is the saturation of the aesthetic botulinum toxin market, which faces limited growth unless innovations or new indications emerge. Conversely, the therapeutic segment continues to expand due to emerging neurodegenerative and movement disorder indications.

Regulatory Environment

Regulatory approvals remain central to market access. Pending or recent approvals for LO-TROL in novel indications can substantially influence its market penetration. Variability across jurisdictions also introduces complexity; for example, FDA approval in the United States versus EMA authorization in Europe dictates the timing and scope of commercialization.

Regulations emphasizing biosimilar competition could present threats or opportunities, depending on LO-TROL's patent protections and its positioning as a differentiated or biosimilar product [4].

Pricing and Reimbursement

Pricing strategies for LO-TROL are influenced by regulatory frameworks and payer negotiations. Reimbursement levels determine patient access and overall revenue streams. The recent trend toward value-based pricing models demands compelling evidence of cost-effectiveness, especially in congested markets where payers favor established brands.

Innovative delivery mechanisms and longer-lasting formulations could command premium pricing, aiding revenue growth. However, price erosion remains a concern due to biosimilar entries and intensified competitive pressures.

Market Penetration and Adoption

Physician prescribing behavior significantly impacts LO-TROL’s market share. Adoption hinges on its perceived efficacy, safety, ease of use, and marketing strategies. Performing well in clinical trials and gaining endorsement from key opinion leaders catalyzes uptake.

In regions where cost considerations dominate, the drug’s affordability relative to competing products affects adoption rates. Additionally, targeted education campaigns about new indications can foster physician familiarity and patient demand.

Financial Trajectory

Revenue Forecasts

Based on market size estimates—estimated global botulinum toxin market valued at approximately USD 6 billion in 2022, with an annual growth rate of around 8% [5]—LO-TROL’s revenue potential aligns with product positioning, market share, and expansion efforts.

Initially, revenue growth may reflect conservative penetration with gradual increases as approvals, clinician acceptance, and payor coverage improve. For instance, assuming a modest 2-3% share of the therapeutic segment within five years could generate annual revenues in the hundreds of millions, contingent upon pricing strategies.

Cost Structure and Profitability

Product development costs have typically been high for botulinum toxins owing to complex manufacturing and stringent regulatory requirements. Post-approval, the focus shifts to production economies of scale, distribution logistics, and marketing.

Margins depend on manufacturing efficiencies, supply chain management, and competition-driven pricing pressures. Strategic alliances and licensing agreements can impact profitability, either through revenue sharing or upfront payments.

Investment and Growth Opportunities

Scaling production facilities, augmenting R&D for novel indications, and geographic expansion constitute potential growth vectors. Emerging markets like Asia-Pacific present significant opportunities, owing to rising disposable incomes and aesthetic consciousness [6].

Moreover, innovations such as longer-lasting formulations or combination therapies can provide competitive advantages, translating into sustained revenue streams.

Industry and External Factors

Factors influencing LO-TROL’s financial trajectory include patent expirations, biosimilar proliferation, technological advancements, and evolving healthcare policies.

Additionally, macroeconomic conditions, such as inflation rates, healthcare expenditure trends, and regulatory reforms, will shape long-term financial outcomes.

Conclusion

LO-TROL’s market dynamics are rooted in a competitive landscape characterized by established leaders and rapid innovation. Its financial trajectory hinges on strategic regulatory approvals, successful market penetration, pricing, and continual enhancement of clinical value propositions. While current outlooks suggest moderate growth aligned with industry trends, targeted efforts in expanding indications, optimizing manufacturing efficiencies, and penetrating emerging markets could significantly bolster its revenue potential over the coming decade.


Key Takeaways

  • LO-TROL operates in a competitive, mature market dominated by established brands like Botox, with growth opportunities in therapeutic and aesthetic segments.
  • Regulatory approvals, especially for new indications, will be pivotal to expanding market access and revenue streams.
  • Pricing strategies and reimbursement policies significantly influence adoption rates, especially amid biosimilar competition.
  • Financial success depends on balancing R&D investments, manufacturing efficiencies, and market expansion, notably in emerging markets.
  • Technological innovations and strategic collaborations can provide competitive differentiation, fostering sustained growth.

Frequently Asked Questions

1. What distinguishes LO-TROL from other botulinum toxin products?
LO-TROL's differentiators include its manufacturing process, duration of effect, and biophysical properties. Its unique formulation may offer advantages in specific indications, although clinical equivalence with competitors remains a key consideration.

2. Which therapeutic indications are most promising for LO-TROL's market expansion?
While existing indications like cervical dystonia and migraine provide steady revenue, expanding into new neurological and urological indications, as well as aesthetic uses, presents significant growth potential.

3. How do biosimilar entries affect LO-TROL’s market share and profitability?
Biosimilars typically exert downward price pressures, challenging profit margins. LO-TROL’s ability to differentiate through clinical efficacy, formulation, or brand strength is critical in mitigating biosimilar impact.

4. What is the outlook for LO-TROL’s entry into emerging markets?
Emerging markets present substantial growth opportunities due to rising healthcare investments and demand for minimally invasive treatments. Successful entry depends on local regulatory approvals, price sensitivity, and distribution channels.

5. What factors could influence LO-TROL’s long-term financial success?
Key factors include regulatory success in gaining approvals, broadening of therapeutic indications, competitive positioning, manufacturing scalability, and strategic partnerships.


Sources

[1] Clinical trials and product indications documentation from regulatory agencies.
[2] Market analyses of aesthetic and therapeutic botulinum toxin segments.
[3] Industry reports on competitive dynamics and market share.
[4] Regulatory policy reviews relevant to biosimilar competition.
[5] Market research on the global botulinum toxin industry.
[6] Regional healthcare expenditure and consumer behavior studies.

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