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Last Updated: December 22, 2024

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-four 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 EPIC PHARMA LLC on November 8th, 1982.

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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 ⤷  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

ACTICLATE CAP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acticlate Caps

Introduction

Acticlate, a brand name for doxycycline hyclate, is a widely used antibiotic in the treatment of various bacterial infections, including those in the dermatology sector. Understanding the market dynamics and financial trajectory of Acticlate Caps is crucial for pharmaceutical companies, investors, and healthcare providers.

Approval and Launch

Acticlate was approved by the FDA on July 25, 2014, and its launch was marked by significant uptake. Almirall, the company behind Acticlate, reported an outstanding launch, with the drug quickly becoming a market leader in total prescriptions just three months after its introduction[5].

Market Performance

The launch of Acticlate contributed substantially to Almirall's financial performance. In the fiscal year 2014, Almirall saw a 13.5% increase in net sales compared to the previous year, largely driven by the success of Acticlate. The drug's strong market performance helped Almirall achieve a market-leading TRx (total prescription) share in the dermatology sector[5].

Revenue and Sales

Acticlate's revenue has been a significant contributor to Almirall's overall financial health. In 2017, Acticlate generated around $8 million in sales, which, although modest compared to other anti-infective drugs, was still a notable figure given the competitive landscape of genericized markets[1].

Competitive Landscape

The antibiotic market, particularly for gram-negative infections, is highly competitive and dominated by generic drugs. This competition has led to lower sales for many branded antibiotics, including Acticlate. However, Acticlate's performance in the dermatology sector has been more resilient due to its specific indications and market positioning[1].

Reimbursement Dynamics

Reimbursement dynamics play a critical role in the financial trajectory of antibiotics like Acticlate. In the U.S., antibiotics are often reimbursed as part of bundled payments for in-patient treatments under Diagnosis Related Groups (DRG) payments. This reimbursement model can make it challenging for hospitals to adopt newer, more expensive antibiotics, as it may result in financial losses for the hospital[1].

Impact of Generic Competition

The genericization of the antibiotic market has significantly impacted the sales of branded drugs like Acticlate. Generic versions of doxycycline hyclate are widely available, which has led to reduced market share and revenue for the branded version. Despite this, Acticlate has maintained a strong presence in the dermatology sector due to its established brand and clinical efficacy[2].

Financial Highlights

In the fiscal year 2014, Almirall's financial performance was bolstered by the success of Acticlate. The company reported a gross margin of 70.1%, up from 66.4% in the previous year, and a significant increase in net sales. The positive financial impact of Acticlate was also reflected in Almirall's R&D expenses, which decreased as a percentage of sales from 18.3% in 2013 to 12.8% in 2014[5].

Future Outlook

The future outlook for Acticlate is influenced by several factors, including market competition, reimbursement policies, and the emergence of new antibiotics. While Acticlate is expected to continue its strong performance in the dermatology sector, its overall sales may be impacted by the broader trends in antibiotic usage and reimbursement.

National Trends in Prescription Drug Expenditures

National trends indicate that prescription drug spending, including antibiotics, is expected to rise by 10.0% to 12.0% in 2024. However, this growth may not be uniform across all sectors, with clinics and nonfederal hospitals experiencing different rates of increase. The impact of new drug approvals, patent expirations, and policy changes will also shape the future financial trajectory of Acticlate[3].

Clinical Significance and Usage

Acticlate is commonly used in the treatment of severe acne and other dermatological conditions. Its clinical efficacy and safety profile have been well-established, making it a preferred choice among dermatologists. However, its usage can be affected by factors such as food intake, which may decrease systemic absorption, although the clinical significance of this is still under review[4].

Conclusion

Acticlate Caps, despite operating in a highly competitive and genericized market, has maintained a strong market presence and contributed significantly to Almirall's financial health. The drug's success is attributed to its strong launch, market positioning in the dermatology sector, and established clinical efficacy.

Key Takeaways

  • Market Approval and Launch: Acticlate was approved in 2014 and had a successful launch, becoming a market leader in dermatology prescriptions.
  • Revenue and Sales: Acticlate generates significant revenue, although it faces competition from generic versions.
  • Reimbursement Dynamics: Reimbursement policies, particularly DRG payments, can affect the adoption of branded antibiotics.
  • Competitive Landscape: The antibiotic market is highly competitive, with generics dominating the market.
  • Future Outlook: Acticlate's future is influenced by market trends, reimbursement policies, and the emergence of new antibiotics.

FAQs

Q: When was Acticlate approved by the FDA? A: Acticlate was approved by the FDA on July 25, 2014[5].

Q: What is the primary use of Acticlate? A: Acticlate is primarily used in the treatment of various bacterial infections, including those in the dermatology sector such as severe acne[4].

Q: How does the reimbursement model affect the sales of Acticlate? A: The reimbursement model, particularly DRG payments, can make it financially challenging for hospitals to adopt newer, more expensive antibiotics like Acticlate[1].

Q: What is the impact of generic competition on Acticlate sales? A: Generic competition has reduced the market share and revenue of Acticlate, although it remains strong in the dermatology sector[2].

Q: What are the national trends in prescription drug expenditures expected to be in 2024? A: Prescription drug spending is expected to rise by 10.0% to 12.0% in 2024, with varying rates of increase across different sectors[3].

Sources

  1. Antibiotic sales and reimbursement Challenges - IDSociety.org
  2. ASX Announcement - Aspect Huntley
  3. National trends in prescription drug expenditures and projections for 2024 - PubMed
  4. Oral Tetracycline-Class Drugs in Dermatology: Impact of Food Intake - MDPI
  5. FY 2014 - Financial Results and Business Update - Almirall

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