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Last Updated: March 24, 2025

TERRA-CORTRIL Drug Patent Profile


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Which patents cover Terra-cortril, and when can generic versions of Terra-cortril launch?

Terra-cortril is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in TERRA-CORTRIL is hydrocortisone acetate; oxytetracycline hydrochloride. There are sixty-seven drug master file entries for this compound. Additional details are available on the hydrocortisone acetate; oxytetracycline hydrochloride profile page.

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Summary for TERRA-CORTRIL
Drug patent expirations by year for TERRA-CORTRIL
Recent Clinical Trials for TERRA-CORTRIL

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SponsorPhase
Children's Oncology GroupPhase 1
National Cancer Institute (NCI)Phase 1
EsPhALL network I-BFM Study GroupPhase 3

See all TERRA-CORTRIL clinical trials

US Patents and Regulatory Information for TERRA-CORTRIL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Pfizer TERRA-CORTRIL hydrocortisone acetate; oxytetracycline hydrochloride SUSPENSION;OPHTHALMIC 061016-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Terra-Cortril

Introduction

Terra-Cortril, a topical ointment containing oxytetracycline and hydrocortisone, is used to treat various skin infections and inflammatory conditions. To understand its market dynamics and financial trajectory, we need to delve into its usage, regulatory environment, and the financial performance of the companies involved in its distribution.

Product Overview

Terra-Cortril Ointment is indicated for the treatment of exudative and secondarily infected eczema, including atopic eczema, primary irritant dermatitis, allergic and seborrhoeic dermatitis, and secondarily infected insect bite reactions[4].

Regulatory Environment

The availability of Terra-Cortril is subject to regulatory oversight. In the European Union, antibiotics like those in Terra-Cortril are closely monitored due to concerns about antimicrobial resistance. The EU has strict guidelines on the over-the-counter (OTC) availability of antibiotics, and Terra-Cortril, being a topical antibiotic, falls under these regulations[1].

Market Availability

Terra-Cortril is available in several European countries, although its availability varies. It is part of a group of OTC antibiotics that are mainly used for topical applications. The EU survey identified that northern European countries have the least amount of OTC antibiotics, while western and eastern Europe have a higher number, with Belgium having a significant share[1].

Sales and Revenue

The sales of Terra-Cortril can be influenced by several factors, including its OTC status and the overall demand for topical antibiotics. Studies have shown that making antibiotics available OTC can lead to significant increases in sales. For instance, the OTC availability of antibiotic eye drops containing chloramphenicol was associated with a 48% sales increase in a British study[1].

Financial Performance of Distributing Companies

Companies like Alliance Pharma, which distribute a range of pharmaceutical and consumer healthcare products, including Terra-Cortril, provide insights into the financial trajectory. Alliance Pharma's annual reports indicate strong revenue growth, partly due to the performance of their consumer healthcare products. In 2018, the company reported a 22% increase in see-through revenue to £124.0m, with like-for-like revenues up 4%[2].

Geographic Performance

The performance of Terra-Cortril can also be analyzed through the geographic reach of its distributors. Alliance Pharma has a significant presence in over 100 countries, with a strong focus on the UK, Republic of Ireland, and Asia Pacific regions. While UK sales were down 5% in 2018 due to various challenges, the company's international footprint, especially in China, showed strong growth[2].

Challenges and Opportunities

Regulatory Challenges

The ongoing concern about antimicrobial resistance poses a significant regulatory challenge. The European Parliament has called for increased awareness against OTC and illegal sales of antimicrobials, which could impact the sales and availability of Terra-Cortril[1].

Market Opportunities

Despite regulatory challenges, there are opportunities for growth. The demand for topical antibiotics remains high, especially for products that combine anti-inflammatory and antibacterial properties like Terra-Cortril. The product's efficacy in treating a range of skin conditions makes it a valuable option for patients.

Side Effects and Safety Concerns

Terra-Cortril, like other topical antibiotics, comes with potential side effects and safety concerns. These include the risk of contact sensitization, secondary infections, and the development of resistant organisms. These factors can influence patient and prescriber preferences, impacting sales[4].

Consumer and Prescriber Preferences

Consumer preferences for convenient and effective treatments drive the demand for OTC products like Terra-Cortril. However, prescribers' concerns about antimicrobial resistance and the potential for misuse can affect prescribing patterns and, by extension, sales.

Competitive Landscape

The market for topical antibiotics is competitive, with various products available for similar indications. Terra-Cortril competes with other products containing different antibiotics and anti-inflammatory agents. The competitive landscape can influence pricing, marketing strategies, and overall market share.

Future Outlook

Given the regulatory environment and the ongoing concerns about antimicrobial resistance, the future outlook for Terra-Cortril is complex. While there is a continued demand for effective topical antibiotics, any changes in regulatory policies or increased scrutiny on OTC antibiotics could impact sales. However, companies like Alliance Pharma are well-positioned to adapt to these changes and continue to grow their market share through strategic acquisitions and international expansion.

Key Takeaways

  • Regulatory Oversight: Terra-Cortril's availability is closely monitored due to concerns about antimicrobial resistance.
  • Market Demand: The product benefits from high demand for topical antibiotics, especially those with combined anti-inflammatory and antibacterial properties.
  • Financial Performance: Distributing companies like Alliance Pharma have shown strong revenue growth, partly driven by consumer healthcare products.
  • Challenges and Opportunities: Regulatory challenges and safety concerns must be balanced against market opportunities and consumer demand.
  • Competitive Landscape: The market is competitive, with various products available for similar indications.

FAQs

What is Terra-Cortril used for?

Terra-Cortril is used to treat exudative and secondarily infected eczema, primary irritant dermatitis, allergic and seborrhoeic dermatitis, and secondarily infected insect bite reactions.

Is Terra-Cortril available over-the-counter?

Yes, Terra-Cortril is available over-the-counter in several European countries, although its availability varies by region.

What are the potential side effects of Terra-Cortril?

Potential side effects include contact sensitization, secondary infections, and the development of resistant organisms. Long-term use can also lead to topical steroid withdrawal syndrome.

How does the regulatory environment impact Terra-Cortril sales?

The regulatory environment, particularly concerns about antimicrobial resistance, can impact the sales and availability of Terra-Cortril. Stricter regulations could reduce its OTC availability.

Which companies distribute Terra-Cortril?

Companies like Alliance Pharma distribute Terra-Cortril as part of their portfolio of pharmaceutical and consumer healthcare products.

Sources

  1. Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway. Eurosurveillance, 2015.
  2. Annual Reports and Accounts 2018. Alliance Pharma.
  3. ExCeL Platinum Suite, London 14-16 November 2018. British Geriatrics Society.
  4. Terra-Cortril ointment - Summary of Product Characteristics (SmPC). Medicines.org.uk.
  5. Federal Register / Vol. 49, No. 181 / Monday, September 17, 1984. Govinfo.gov.

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