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Last Updated: December 25, 2024

HYTONE Drug Patent Profile


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

Hytone is a drug marketed by Valeant Intl and Dermik Labs and is included in three NDAs.

The generic ingredient in HYTONE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hytone

A generic version of HYTONE was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Summary for HYTONE
Drug patent expirations by year for HYTONE
Recent Clinical Trials for HYTONE

Identify potential brand extensions & 505(b)(2) entrants

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

See all HYTONE clinical trials

US Patents and Regulatory Information for HYTONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Intl HYTONE hydrocortisone CREAM;TOPICAL 080472-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Intl HYTONE hydrocortisone LOTION;TOPICAL 080473-004 Nov 30, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Intl HYTONE hydrocortisone CREAM;TOPICAL 080472-004 Approved Prior to Jan 1, 1982 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

EU/EMA Drug Approvals for HYTONE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185
Treatment of adrenal insufficiency in adults.
Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

HYTONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Hytone

Introduction

Hytone, a topical hydrocortisone product, is a corticosteroid used to relieve skin conditions such as redness, itching, and swelling. To understand the market dynamics and financial trajectory of Hytone, it is crucial to analyze various factors including competition, regulatory environment, market trends, and the financial implications of its use and distribution.

Market Competition

The pharmaceutical market, particularly for generic and topical steroids, is highly competitive. Hytone, now discontinued under its brand name, faces competition from numerous generic equivalents and other brand-name products. Companies like Taro Pharmaceutical Industries, which operate in this space, highlight the intense competition from generic manufacturers, original brand-name companies, and new drug manufacturers[1].

Generic Competition

Since Hytone's generic versions are available, the market is flooded with cheaper alternatives, which can significantly impact the pricing and market share of any branded or proprietary versions. Generic manufacturers often have lower production costs and can offer their products at a lower price, making it challenging for branded products to maintain market share[1].

Brand Name Competition

Even though Hytone is no longer available under its brand name, other brand-name products like Ala-Cort, Ala-Scalp HP, and Anusol HC continue to compete in the market. These products, while offering similar benefits, may have different formulations or marketing strategies that attract consumers[4].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of pharmaceutical products. For Hytone, the FDA's approval of generic versions has opened the market to multiple competitors. Regulatory changes can also affect pricing strategies and the overall profitability of pharmaceutical companies. For instance, government incentives and regulations can influence the development and pricing of drugs, especially those targeting small patient populations[3].

Market Trends

Shift to Precision Medicines

The pharmaceutical industry is increasingly focusing on precision medicines and targeted therapies. While Hytone is a broad-spectrum topical steroid, the trend towards precision medicines could lead to the development of more targeted treatments, potentially reducing the demand for general topical steroids[3].

Consolidation in Distribution

The distribution chain for pharmaceutical products, including Hytone, is undergoing significant consolidation. Large buying groups and retail chains are gaining more purchasing leverage, which can lead to increased pricing pressures on manufacturers. This consolidation can impact the profitability of companies that rely heavily on a few major customers[1].

Financial Trajectory

Revenue Impact

The financial trajectory of Hytone is influenced by its market share and pricing. With the product no longer available under its brand name and the presence of numerous generic alternatives, the revenue from Hytone has likely declined. Companies that once relied on Hytone for significant revenue may need to diversify their product portfolios to maintain financial stability[1].

Pricing Pressures

Pricing pressures are a significant challenge in the pharmaceutical industry. The emergence of large buying groups and managed care organizations can negotiate price discounts, further eroding the profitability of products like Hytone. Additionally, the competition from generic and brand-name products can drive prices down, affecting the financial performance of the company[1].

Technological and Innovational Changes

Rapid Technological Change

The pharmaceutical industry is undergoing rapid technological changes, which can make existing products obsolete. New developments in drug delivery systems, formulations, and targeted therapies could render traditional topical steroids like Hytone less competitive. Companies must invest in research and development to stay competitive and adapt to these changes[1].

Customer and Distribution Dynamics

Concentration of Sales

For many pharmaceutical companies, a significant portion of sales comes from a relatively small number of wholesalers, retail drug chains, and mass merchandisers. Any financial difficulties or changes in buying patterns of these major customers can have a material adverse effect on the business and financial position of the company[1].

Side Effects and Safety Concerns

Medical and Financial Implications

The use of Hytone, like other topical steroids, comes with potential side effects such as skin thinning, adrenal gland problems, and other systemic effects. These safety concerns can impact consumer trust and usage, thereby affecting the financial performance of the product. Continuous monitoring and medical follow-up are essential to mitigate these risks[4].

Key Takeaways

  • High Competition: The market for topical steroids like Hytone is highly competitive, with numerous generic and brand-name alternatives.
  • Regulatory Impact: FDA approvals and regulatory changes significantly influence the market dynamics and pricing strategies.
  • Market Trends: The shift towards precision medicines and consolidation in distribution chains affect the demand and profitability of traditional products.
  • Financial Stability: The financial trajectory of Hytone is challenged by pricing pressures, competition, and technological changes.
  • Safety Concerns: Continuous monitoring of side effects is crucial to maintain consumer trust and mitigate financial risks.

FAQs

Q: Why has Hytone been discontinued under its brand name?

A: Hytone has been discontinued under its brand name, but generic versions of hydrocortisone topical are still available and approved by the FDA[4].

Q: How does competition affect the pricing of Hytone?

A: The presence of numerous generic and brand-name competitors drives prices down, making it challenging for branded products to maintain profitability[1].

Q: What are the potential side effects of using Hytone?

A: Side effects include skin thinning, adrenal gland problems, and other systemic effects. Regular medical follow-up is necessary to monitor these risks[4].

Q: How does the shift to precision medicines impact Hytone?

A: The trend towards precision medicines could lead to the development of more targeted treatments, potentially reducing the demand for broad-spectrum topical steroids like Hytone[3].

Q: What role do large buying groups play in the distribution of Hytone?

A: Large buying groups and retail chains gain purchasing leverage, leading to increased pricing pressures and potentially affecting the profitability of companies that rely on these customers[1].

Sources

  1. Taro Pharmaceutical Industries Ltd. - Risks Relating to Our Industry
  2. UNM President - Chronological Review
  3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - National Bureau of Economic Research
  4. Hytone Advanced Patient Information - Drugs.com
  5. Pulsed Electromagnetic Stimulation - Aetna Medical Clinical Policy Bulletins

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