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Last Updated: December 22, 2024

ACTISITE Drug Patent Profile


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

Actisite is a drug marketed by Schiff And Co and is included in one NDA.

The generic ingredient in ACTISITE is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Actisite

A generic version of ACTISITE was approved as tetracycline hydrochloride by WATSON LABS on December 31st, 1969.

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Summary for ACTISITE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 84
Patent Applications: 4,660
DailyMed Link:ACTISITE at DailyMed
Drug patent expirations by year for ACTISITE

US Patents and Regulatory Information for ACTISITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schiff And Co ACTISITE tetracycline hydrochloride FIBER, EXTENDED RELEASE;PERIODONTAL 050653-001 Mar 25, 1994 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ACTISITE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Atridox (ACTISITE)

Introduction

Atridox, also known as ACTISITE, is a periodontal disease therapeutic agent that has been a significant player in the dental pharmaceutical market. To understand its market dynamics and financial trajectory, it is crucial to delve into various aspects of the drug's performance, market trends, and the broader pharmaceutical industry context.

Market Size and Growth

The global periodontal disease therapeutics market, which includes Atridox, was estimated to reach USD 160 million by 2020, growing at a CAGR of 8.2% from 2016 to 2020[1].

Drug Type and Market Segmentation

Atridox is classified under the category of periodontal disease therapeutics, which also includes other drugs like Arestin, Doxycycline, Metronidazole, Minocycline, and PerioChip. The market segmentation based on drug types helps in understanding the competitive landscape and the specific market share of Atridox[1].

Geographic Market

The market for periodontal disease therapeutics, including Atridox, is segmented geographically into regions such as North America, Latin America, Europe, Asia Pacific, and the Rest of the World. This segmentation is crucial for understanding regional demand and market penetration[1].

Sales Performance and Trends

Quarterly and Annual Sales

The sales performance of Atridox can be analyzed in the context of quarterly and annual sales trends. Typically, antimicrobial drugs, including those for periodontal diseases, show increasing sales in the first few years after launch, followed by a plateau or slight decline as other drugs enter the market. For example, many antimicrobial drugs reach quarterly sales of $5 to $10 million after 1-2 years and up to $10 to $40 million after about 5 years on the market[3].

Comparative Added Clinical Benefit

Drugs with higher comparative added clinical benefit scores tend to have higher early market sales. This trend suggests that Atridox, if it has a strong clinical benefit profile, would likely see robust sales in its initial years on the market[3].

Financial Trajectory

Revenue and Expenses

For a drug like Atridox, the financial trajectory is closely tied to its sales performance and the overall market conditions. Companies that produce such drugs typically incur significant research and development (R&D) expenses, as well as general and administrative (G&A) expenses. For instance, Azitra Inc., a company involved in similar therapeutic areas, reported R&D expenses of $1.0 million and G&A expenses of $1.9 million in Q3 2024[5].

Cash Flow and Funding

The financial health of a company producing Atridox would also depend on its cash flow and funding. Many pharmaceutical companies, especially those in the development stage, require additional financing through public offerings, private placements, or collaborations. Acasti Pharma Inc., for example, has relied on such financing methods to fund its operations and clinical trials[2].

Competitive Landscape

Market Concentration

The pharmaceutical industry, including the segment for periodontal disease therapeutics, has seen significant consolidation through mergers and acquisitions. This trend can impact competition and innovation. However, it also presents opportunities for companies to leverage economies of scale and enhance their marketing and distribution capabilities[4].

Innovation and Competition

Despite concerns about market concentration, mergers can also promote innovation by allowing companies to focus resources on promising drug candidates. For Atridox, being part of a larger pharmaceutical portfolio could enhance its market reach and competitive positioning[4].

Regulatory Environment

FDA Approvals and Designations

Regulatory approvals and designations are critical for the financial trajectory of any drug. For instance, receiving Fast Track designation from the FDA, as seen with Azitra's ATR-04, can significantly impact the drug's development timeline and market potential[5].

Intellectual Property and Patents

A strong intellectual property portfolio is essential for protecting the market share of a drug like Atridox. Companies often strengthen their IP portfolios through newly granted and allowed patents, which can provide a competitive edge and protect against generic competition[5].

Key Takeaways

  • Market Growth: The periodontal disease therapeutics market, including Atridox, has shown significant growth, with a projected market size of USD 160 million by 2020.
  • Sales Trends: Atridox's sales are likely to follow the trend of increasing sales in the initial years after launch, with a potential plateau later.
  • Financial Health: The financial trajectory of Atridox is influenced by R&D and G&A expenses, as well as the need for continuous funding.
  • Competitive Landscape: Market concentration and mergers can impact competition but also offer opportunities for enhanced market reach and innovation.
  • Regulatory Environment: Regulatory approvals and designations are crucial for the drug's market potential.
  • Intellectual Property: A strong IP portfolio is vital for protecting market share.

FAQs

What is the estimated market size for periodontal disease therapeutics by 2020?

The global periodontal disease therapeutics market was estimated to reach USD 160 million by 2020[1].

How does the sales performance of Atridox compare to other antimicrobial drugs?

Atridox's sales performance is likely to follow the trend of other antimicrobial drugs, with increasing sales in the first few years after launch and a potential plateau later[3].

What are the key expenses for companies producing drugs like Atridox?

Key expenses include research and development (R&D) and general and administrative (G&A) expenses[5].

How do mergers and acquisitions impact the pharmaceutical industry?

Mergers and acquisitions can impact competition but also promote innovation and enhance market reach through economies of scale[4].

What is the importance of regulatory approvals for drugs like Atridox?

Regulatory approvals and designations, such as Fast Track designation, are critical for the drug's development timeline and market potential[5].

Why is a strong intellectual property portfolio important for Atridox?

A strong IP portfolio protects the market share of Atridox and guards against generic competition[5].

Sources

  1. Biopharma Dive: "Periodontal Disease Therapeutics Market USD 160 Million by 2020"[1]
  2. Acasti Pharma Inc.: "Acasti Pharma Inc. SEC Filings"[2]
  3. NCBI: "MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs"[3]
  4. Duke University Scholarship: "Pharmaceutical M&A Activity: Effects on Prices, Innovation, and Competition"[4]
  5. Azitra, Inc.: "Azitra, Inc. Announces Q3 2024 Financial Results and Provides Business Updates"[5]

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