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Last Updated: December 22, 2024

HYDROCORTISONE AND ACETIC ACID Drug Patent Profile


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Which patents cover Hydrocortisone And Acetic Acid, and what generic alternatives are available?

Hydrocortisone And Acetic Acid is a drug marketed by Bausch And Lomb, Cosette, Taro, and Wockhardt. and is included in four NDAs.

The generic ingredient in HYDROCORTISONE AND ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.

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Summary for HYDROCORTISONE AND ACETIC ACID
US Patents:0
Applicants:4
NDAs:4
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 4,533
What excipients (inactive ingredients) are in HYDROCORTISONE AND ACETIC ACID?HYDROCORTISONE AND ACETIC ACID excipients list
DailyMed Link:HYDROCORTISONE AND ACETIC ACID at DailyMed
Drug patent expirations by year for HYDROCORTISONE AND ACETIC ACID
Pharmacology for HYDROCORTISONE AND ACETIC ACID

US Patents and Regulatory Information for HYDROCORTISONE AND ACETIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040097-001 Oct 31, 1994 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040168-001 Aug 30, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cosette HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040609-001 Feb 6, 2006 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 088759-001 Mar 4, 1985 AT RX Yes Yes ⤷  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

HYDROCORTISONE AND ACETIC ACID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocortisone and Acetic Acid

Introduction

Hydrocortisone and Acetic Acid, a combination drug used primarily for the treatment of superficial infections of the external auditory canal, is a significant player in the pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this drug.

Market Size and Growth Projections

The Hydrocortisone Acetate Market, which includes formulations like Hydrocortisone and Acetic Acid, has been experiencing rapid growth. As of 2023, the market size was valued at several billion USD and is projected to reach even higher figures by 2031, exhibiting a substantial CAGR during the forecast period[1].

Segmentation and Application

The market for Hydrocortisone and Acetic Acid is segmented based on type (injection, tablet, ointment, eye drops, others) and application (hospital, clinic, others). Geographically, the market spans across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region is expected to be a significant contributor to the market growth due to the expanding pharmaceutical sector and increasing geriatric population[1].

Clinical Use and Indications

Hydrocortisone and Acetic Acid Otic Solution is specifically designed for the treatment of superficial infections of the external auditory canal, complicated by inflammation. The solution contains hydrocortisone (1%) as an anti-inflammatory, antiallergic, and antipruritic agent, and acetic acid (2%) as an antibacterial and antifungal agent. The combination is effective in treating infections caused by susceptible organisms[2].

Market Drivers

Several factors drive the growth of the Hydrocortisone and Acetic Acid market:

  • Increasing Prevalence of Ear Infections: The rising incidence of ear infections, particularly in pediatric and geriatric populations, fuels the demand for effective treatments like Hydrocortisone and Acetic Acid.
  • Advancements in Pharmaceutical Formulations: Continuous improvements in the formulation and delivery of otic solutions enhance patient compliance and treatment efficacy.
  • Expanding Healthcare Infrastructure: Growing healthcare infrastructure, especially in emerging markets, increases access to these medications[1].

Market Restraints

Despite the positive growth trends, there are several restraints to consider:

  • Contraindications and Side Effects: The drug is contraindicated in cases of hypersensitivity, herpes simplex, vaccinia, and varicella, and can cause transient stinging or burning upon application. These factors can limit its use in certain patient populations[2].
  • Competition from Generic and Authorized Generic Drugs: The presence of authorized generic drugs can reduce the market share and revenues of brand-name drugs. Authorized generics can lower retail and wholesale prices, making the brand-name version less competitive[3].

Financial Impact of Authorized Generics

Authorized generics play a significant role in the financial dynamics of the Hydrocortisone and Acetic Acid market. During the 180-day exclusivity period, authorized generics can reduce retail generic prices by 4-8% and wholesale prices by 7-14% compared to periods without authorized generic competition. This competition also reduces the revenues of the first-filer generic manufacturer by 40-52% during the exclusivity period and persists even after the exclusivity ends[3].

Pricing and Medicare Coverage

Hydrocortisone and Acetic Acid is generally covered by Medicare prescription drug plans, often listed on Tier 1 of the formulary, which means lower out-of-pocket costs for patients. However, the cost can vary based on the coverage stage and the specific plan. Discounts and other cost-saving strategies can also be employed to reduce the financial burden on patients[5].

Regional Market Analysis

The Asia-Pacific region is anticipated to be a major contributor to the market growth due to the rapid expansion of the pharmaceutical sector and the increasing demand for geriatric care. North America and Europe also represent significant markets, driven by advanced healthcare systems and high patient awareness[1].

Competitive Landscape

The market for Hydrocortisone and Acetic Acid is competitive, with several key players involved in manufacturing and distribution. Companies like Cosette Pharmaceuticals, Inc., are prominent in this space, ensuring a steady supply of the drug to meet market demands[2].

Economic and Regulatory Factors

Economic factors such as pricing strategies, regulatory approvals, and patent litigation play crucial roles in shaping the market. The presence of authorized generics, for instance, can influence patent challenge decisions by generic manufacturers, particularly in smaller markets[3].

Consumer Behavior and Preferences

Patient compliance and preference for easy-to-use formulations are critical in driving the demand for Hydrocortisone and Acetic Acid. The solution's effectiveness in treating ear infections and its relatively low side effect profile contribute to its popularity among both patients and healthcare providers[2].

Future Outlook

The future outlook for Hydrocortisone and Acetic Acid is positive, driven by increasing demand for effective treatments for ear infections and the expanding pharmaceutical sector. However, the market will need to navigate the challenges posed by authorized generics and other competitive forces to maintain its growth trajectory.

Key Takeaways

  • Market Growth: The Hydrocortisone Acetate Market is expected to grow significantly from 2023 to 2031.
  • Segmentation: The market is segmented by type and application, with a strong presence in hospitals and clinics.
  • Clinical Use: Hydrocortisone and Acetic Acid is used for treating superficial infections of the external auditory canal.
  • Market Drivers: Increasing prevalence of ear infections, advancements in pharmaceutical formulations, and expanding healthcare infrastructure drive market growth.
  • Market Restraints: Contraindications, side effects, and competition from authorized generics are key restraints.
  • Financial Impact: Authorized generics significantly impact pricing and revenues in the market.
  • Regional Analysis: Asia-Pacific, North America, and Europe are key regions driving market growth.

FAQs

What is Hydrocortisone and Acetic Acid used for?

Hydrocortisone and Acetic Acid Otic Solution is used for the treatment of superficial infections of the external auditory canal complicated by inflammation.

Is Hydrocortisone and Acetic Acid covered by Medicare?

Yes, Hydrocortisone and Acetic Acid is typically covered by Medicare prescription drug plans, often listed on Tier 1 of the formulary.

How does the presence of authorized generics affect the market?

Authorized generics reduce retail and wholesale prices, lower revenues for the first-filer generic manufacturer, and can influence patent challenge decisions by generic manufacturers.

What are the key drivers of the Hydrocortisone and Acetic Acid market?

Key drivers include the increasing prevalence of ear infections, advancements in pharmaceutical formulations, and the expanding healthcare infrastructure.

What are the potential side effects of Hydrocortisone and Acetic Acid?

Common side effects include transient stinging or burning upon application, and it is contraindicated in cases of hypersensitivity, herpes simplex, vaccinia, and varicella.

Sources

  1. Market Research Intellect: Hydrocortisone Acetate Market Size, Scope And Forecast Report.
  2. Drugs.com: Hydrocortisone and Acetic Acid: Package Insert / Prescribing Info.
  3. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.
  4. PS Market Research: Acetic Anhydride Market Outlook | Revenue Forecast, 2030.
  5. GoodRx: Hydrocortisone / Acetic Acid Medicare Coverage and Co-Pay Details.

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