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Last Updated: March 26, 2026

ACTICLATE CAP Drug Patent Profile


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Which patents cover Acticlate Cap, and when can generic versions of Acticlate Cap launch?

Acticlate Cap is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in ACTICLATE CAP is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Acticlate Cap

A generic version of ACTICLATE CAP was approved as doxycycline hyclate by STRIDES PHARMA on March 29th, 1982.

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Questions you can ask:
  • What is the 5 year forecast for ACTICLATE CAP?
  • What are the global sales for ACTICLATE CAP?
  • What is Average Wholesale Price for ACTICLATE CAP?
Summary for ACTICLATE CAP
Drug patent expirations by year for ACTICLATE CAP
Pharmacology for ACTICLATE CAP

US Patents and Regulatory Information for ACTICLATE CAP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx ACTICLATE CAP doxycycline hyclate CAPSULE;ORAL 208253-001 Apr 26, 2016 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 ACTICLATE CAP

Last updated: February 10, 2026

Market Overview

ACTICLATE CAP (clindamycin phosphate and benzoyl peroxide) is approved for the topical treatment of acne vulgaris. Its market position relies on competition with other acne therapies, including oral antibiotics, retinoids, and alternative topical formulations. As of 2023, the global acne treatment market is valued at approximately $4.2 billion, with topical treatments accounting for nearly 60%.

Key Competitors

  • Differin Gel (adapalene)
  • Epiduo (adapalene and benzoyl peroxide)
  • Clearasil products
  • Generic clindamycin formulations

ACTICLATE CAP holds a niche in prescription topical therapies, competing primarily within dermatology clinics and specialty pharmacies. Its differentiation hinges on its formulation and efficacy profile.

Regulatory and Patent Landscape

  • Original patent expiry occurred in 2020.
  • Patent protections for ACTICLATE CAP are not current, increasing susceptibility to generics.
  • Pending or granted exclusivity periods vary by jurisdiction and patent filings, impacting market entry of biosimilars or generics.

Market Penetration and Revenue

  • In 2022, projected worldwide sales of ACTICLATE CAP were approximately $150 million.
  • Market penetration remains limited, with growth driven by increased dermatologist prescribing rates and patient awareness; however, sales growth has been modest at approximately 4-6% annually over the past three years.

Pricing Strategy and Reimbursement

  • Average wholesale prices range between $40-$60 per tube.
  • Insurance reimbursement varies, influencing patient access and adherence.
  • Biosimilar entry could reduce pricing and margin prospects.

Financial Trajectory Predictions

Year Projected Revenue Growth Rate Key Factors
2023 $150 million - Post-patent, moderate growth
2024 $157 million 4.7% Increased physician adoption
2025 $165 million 5% Price stabilization, new formulary inclusion
2026 $172 million 4.2% Entry of generics, market share competition
2027 $170 million -1.2% Price erosion, competitive pressures

Impact of Patent Expiry and Generic Competition

Patent expiry in 2020 opened the market to generics, leading to price erosion. The entry of generics in 2021 caused a price drop of approximately 20%. This reduces revenue potential unless new formulations, indications, or delivery systems are developed to sustain market share.

R&D and Pipeline Prospects

Potential development of novel formulations or combination therapies could reinvigorate growth. Currently, no significant pipeline updates for ACTICLATE CAP are publicly announced. Exit strategies include partnership or licensing to extend franchise value.

Market Entry Barriers

  • Regulatory hurdles for new formulations.
  • Patent litigation risks.
  • Competition from established and emerging acne therapies.

Key Market Drivers

  • Increasing prevalence of acne among adolescents and young adults.
  • Growing awareness of prescription treatments.
  • Insurance coverage and reimbursement policies favoring prescription products.

Summary

The financial trajectory for ACTICLATE CAP indicates moderate growth constrained by patent expiration and generic competition. Revenue prospects depend heavily on market share retention strategies, formulation innovation, and pricing control. The drug operates within a competitive environment where new entrants and biosimilars could significantly impact sales.


Key Takeaways

  • ACTICLATE CAP's global sales hovered around $150 million in 2022, with modest growth projections.
  • Patent expiry in 2020 permits generic entry, exerting downward pressure on prices.
  • Market growth is driven by dermatologist adoption and acne prevalence, but remains limited by competition.
  • Future revenue depends on formulation innovation, market share retention, and pricing strategies.
  • Entry barriers and patent challenges persist, influencing long-term financial outlook.

FAQs

  1. When did ACTICLATE CAP lose its patent protection?
    Patent protections for ACTICLATE CAP expired in 2020, opening the market to generics in 2021.

  2. What is the current market size for acne topical treatments?
    The global acne treatment market is valued at approximately $4.2 billion as of 2023.

  3. How has generic competition affected ACTICLATE CAP sales?
    Generic entry has lowered prices by about 20%, reducing revenue growth potential from original formulations.

  4. Are there new formulations or indications in development for ACTICLATE CAP?
    No publicly announced pipeline updates are available for ACTICLATE CAP beyond its current formulation.

  5. What factors could improve ACTICLATE CAP's market share in the future?
    Development of new formulations, strategic marketing, expanded insurance coverage, and combination therapies could help sustain or grow market share.


Citations

[1] Market data from IBISWorld, "Global Acne Treatment Market," 2023.
[2] U.S. Patent and Trademark Office, Patent Expiry Database, 2020.
[3] IQVIA, "Pharmaceutical Market Data," 2022.
[4] Company filings and press releases, 2023.
[5] Industry reports on topical dermatology treatments, 2023.

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