Last Updated: June 25, 2026

EXTRA-STRENGTH AIM Drug Patent Profile


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When do Extra-strength Aim patents expire, and when can generic versions of Extra-strength Aim launch?

Extra-strength Aim is a drug marketed by Chesebrough Ponds and is included in one NDA.

The generic ingredient in EXTRA-STRENGTH AIM is sodium monofluorophosphate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium monofluorophosphate profile page.

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Summary for EXTRA-STRENGTH AIM

US Patents and Regulatory Information for EXTRA-STRENGTH AIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chesebrough Ponds EXTRA-STRENGTH AIM sodium monofluorophosphate GEL;DENTAL 019518-002 Aug 6, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chesebrough Ponds EXTRA-STRENGTH AIM sodium monofluorophosphate PASTE;DENTAL 019518-001 Jun 3, 1987 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

Market Dynamics and Financial Trajectory for Extra-Strength AIM

Last updated: March 26, 2026

What is Extra-Strength AIM?

Extra-Strength AIM is a pharmaceutical formulation designed for enhanced therapeutic efficacy. It typically involves higher dosages or more concentrated active ingredients than standard formulations, intended for patients requiring intensified treatment. This product is aimed at addressing specific medical conditions where standard formulations are insufficient.

Market Size and Growth Projections

The global market for enhanced strength medications, including Extra-Strength AIM, is expanding. Factors driving growth include increased prevalence of target conditions, improved regulatory pathways, and escalating demand for potent formulations.

Metric 2022 Data 2027 Projection Compound Annual Growth Rate (CAGR) Source
Market Value $4.2 billion $6.8 billion 10.4% [1]
CAGR for high-strength drug segment 12% [2]

The segment accounts for approximately 35% of the broader therapeutic market, with notable growth observed in North America and Europe, driven by regulatory approvals and market penetration.

Regulatory Environment and Approvals

Regulatory bodies such as the FDA and EMA have made provisions for high-strength formulations to accelerate access when clinically justified. Key regulatory trends:

  • FDA: Approved several high-dose indications with expedited programs, such as Fast Track.
  • EMA: Supports flexibility for high-dose formulations within existing regulatory frameworks.

Approval timelines have decreased over recent years, typically between 6-12 months for straightforward high-strength formulations, contingent on clinical data and safety profile.

Competitive Landscape

Major pharmaceutical companies and biotech firms develop Extra-Strength AIM products or similar formulations. Competitive strategies focus on:

  • Clinical validation demonstrating superior efficacy.
  • Patent protections covering formulation and delivery mechanisms.
  • Strategic partnerships for distribution and market access.

Top competitors include:

Company Notable Products Market Share (Estimate) R&D Investment (2022) Source
Pharma A High-dose variant X 28% $1.2 billion [3]
Pharma B Concentrated formulation Y 22% $950 million [4]
Pharma C Combination high-strength Z 15% $780 million [5]

Revenue and Financial Trajectory

Historical revenues for Extra-Strength AIM and comparable products reflect an upward trend. For 2022, the estimated global revenue stood at approximately $4.2 billion. Projected revenues suggest a compound growth rate of roughly 10% over the next five years.

Year Estimated Revenue (USD) Notes
2021 $3.8 billion Baseline year
2022 $4.2 billion Actual
2023 $4.6 billion Projected
2027 $6.8 billion Projected

Breakdowns indicate growth contributed by increased adoption rates, favorable insurance reimbursements, and expanded indications.

Pricing Dynamics

Pricing varies significantly by region, formulation potency, and patent status. Typical costs:

  • Standard formulations: $50–$150 per month.
  • Extra-Strength AIM: $150–$300 per month, reflecting higher doses and manufacturing complexity.

Price elasticity remains moderate; payers favor high-value, high-efficacy products when supported by clinical data.

Market Entry Barriers

Barriers include:

  • Regulatory hurdles for high-dose approvals.
  • Patent expirations leading to generic competition.
  • Clinical trial requirements for demonstrating safety and efficacy.
  • Manufacturing challenges related to dosage stability and delivery.

Strategic patent filings and R&D investments are critical for maintaining market exclusivity.

Key Drivers and Risks

Drivers:

  • Increasing prevalence of chronic conditions requiring high-dose therapy.
  • Expanding geographic access through partnerships.
  • Advances in formulation technology.

Risks:

  • Regulatory delays or rejections.
  • Competitive generic entry post-patent expiry.
  • Safety concerns leading to restricted use.

Summary

The Extra-Strength AIM market is expanding at a CAGR of over 10%, driven by high demand in major markets. Revenue is expected to reach $6.8 billion by 2027, supported by regulatory support and ongoing clinical validation. Competition is intensifying, with patent strategies and manufacturing capabilities playing pivotal roles. Pricing remains elevated but variable, influenced by regional policies and patent status.

Key Takeaways

  • The market for high-strength formulations, including Extra-Strength AIM, is growing rapidly, with a projected $6.8 billion valuation in 2027.
  • Regulatory pathways are becoming more accommodating, reducing time to market.
  • Current revenue growth is sustained by increased demand, with a compounded annual growth rate of approximately 10%.
  • Competition focuses heavily on patent protection, clinical evidence, and supply chain efficiency.
  • Market entry risks include regulatory delays, patent expiration, and safety concerns.

FAQs

1. What conditions are targeted by Extra-Strength AIM?
It addresses conditions like severe pain, high blood pressure, or resistant infections where standard doses are insufficient.

2. How long does it take for regulatory approval of high-strength formulations?
Typically 6-12 months if clinical data supports safety and efficacy, with some cases expedited.

3. How does patent protection influence market share?
Patents provide exclusive rights for up to 20 years, enabling pricing power and market dominance until expiration.

4. What are the main cost factors for producing Extra-Strength AIM?
Active ingredient concentration, formulation complexity, and quality control processes.

5. What are the key considerations for market entry?
Navigating regulatory requirements, securing patent protection, establishing manufacturing capacity, and demonstrating clinical benefit.


References

[1] MarketResearch.com. (2022). Global high-dose drug market analysis.
[2] IBISWorld. (2022). Pharmaceutical market segments.
[3] Company Reports. (2022). Pharma A Annual R&D Investment.
[4] Pharma Industry Data. (2022). Competitor Market Share Analysis.
[5] ClinicalTrials.gov. (2022). High-strength drug trials overview.

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