Last Updated: November 13, 2026

paramethasone acetate - Profile

« Back to Dashboard


What are the generic sources for paramethasone acetate and what is the scope of patent protection?

Paramethasone acetate is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for paramethasone acetate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for paramethasone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for paramethasone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-005 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
Lilly HALDRONE paramethasone acetate TABLET;ORAL 012772-006 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Last updated: February 3, 2026

What is the Current Investment Outlook for Paramethasone Acetate?

Paramethasone acetate remains a niche corticosteroid used in both pharmaceutical formulations and seasonal allergy treatments. Its global market is characterized by stable demand due to consistent use in anti-inflammatory and immunosuppressive therapies. The investment interest stems from the drug's widespread application, production stability, and ongoing patent expirations, which influence manufacturing and competitive landscapes.

What Are the Key Market Drivers and Trends?

The primary drivers include:

  • High Prevalence of Autoimmune and Allergic Conditions: Increasing cases of asthma, dermatitis, and rheumatoid arthritis sustain demand.
  • Cost-Effective Production: Generic manufacturing drives price reduction, expanding access and usage.
  • Regulatory Approvals: Ongoing approvals for formulations and new delivery systems expand therapeutic options.
  • Emerging Markets: Growth in Asia-Pacific, driven by rising healthcare infrastructure and demand, enhances market size.

Trends include increased focus on:

  • Higher-dose formulations and novel delivery methods: Inhalers and topical applications extend molecule utility.
  • Combination therapies: Incorporation with other active ingredients to enhance therapeutic efficacy.

What Are the Fundamentals of Paramethasone Acetate?

Chemical Composition and Production

Paramethasone acetate is a synthetic glucocorticoid obtained via chemical synthesis, similar to other corticosteroids such as dexamethasone. Its production involves multi-step chemical synthesis with key intermediates derived from cortisone derivatives. The process is well-established, with generic manufacturers holding significant market share.

Manufacturing Landscape

Four major regions produce paramethasone acetate:

Region Major Manufacturers Production Capacity Regulatory Environment
North America Pfizer, Mylan High Stringent FDA regulations, generic-friendly policies
Europe Sandoz, Teva Moderate EMA approvals, emphasis on quality control
Asia-Pacific Intas, Hanmi, Cipla Growing Varying standards, increasing regulatory harmonization
Latin America Local generic firms Limited Less regulatory oversight, rising regional demand

Patent Landscape

Most patents associated with paramethasone acetate have expired or are nearing expiration, decreasing barriers to generic entry. New formulations or delivery mechanism patents may provide innovation opportunities but are limited.

Supply Chain and Pricing

Supply chains are consolidated among large generic firms, ensuring price competition. The average global price for a 30 mg vial ranges between $2 - $5, subject to regional pricing regulations and patent status.

Regulatory Status

Paramethasone acetate is approved predominantly in generic form. It is included in formularies across most developed nations. No recent major regulatory hurdles have emerged, but the molecule faces scrutiny over long-term safety in some regions.

What Are the Investment Risks and Challenges?

Competition from Alternatives

  • The presence of multiple corticosteroids, such as dexamethasone and prednisone, creates substitution risks.
  • Development of biologics for autoimmune indications could cannibalize traditional corticosteroid markets.

Regulatory and Legal Risks

  • Variations in regulatory standards across regions can delay approvals.
  • Patent litigations or lawsuits over formulations could impact market access.

Pricing Pressures

Healthcare systems aim to reduce costs, leading to increased price competition among generics, reducing profitability margins.

Manufacturing Risks

Supply chain disruptions, quality control issues, or geopolitical factors could impact production stability.

What Is the Financial Outlook?

Financial metrics for agencies manufacturing paramethasone acetate remain stable, with unit prices declining gradually as competition intensifies. For companies with established generic operations, margins persist around 20% to 30%. Investment in new formulations or delivery mechanisms, such as inhalers, may result in higher margins (~35-45%) but involve additional R&D costs and regulatory hurdles.

Which Market Segments Present Investment Opportunities?

  • Generic manufacturing: Continues to be a low-risk, stable income source.
  • New formulation development: Inhalable or topical forms can command premium pricing.
  • Emerging markets: Expansion into regions with unmet needs and expanding healthcare access offers growth prospects.
  • Partnerships and licensing: Collaborations with regional firms can reduce entry barriers.

What Are the Key Takeaways?

  • Paramethasone acetate's market remains stable with consistent demand in anti-inflammatory therapy.
  • Patent expirations facilitate generic proliferation, exerting downward pressure on prices.
  • Growth is driven by emerging markets and innovation in delivery methods.
  • Regulatory, competition, and pricing pressures constitute primary risks.
  • Investment opportunities lie in generics, new formulations, and emerging markets.

FAQs

1. How does the patent status of paramethasone acetate impact investment?
Most patents have expired, favoring generic entry and lowering barriers, leading to price competition but also stable demand.

2. Are there notable innovations in the delivery of paramethasone acetate?
Yes, inhalable forms and topical formulations are under development, targeting improved efficacy and patient compliance.

3. What regions offer the highest growth potential for paramethasone acetate?
Asia-Pacific presents significant opportunities due to expanding healthcare infrastructure and rising autoimmune disease prevalence.

4. What legal challenges could affect its market?
Patent litigations or regulatory delays in certain regions could constrain market entry or product launches.

5. How does the competitive landscape influence profitability?
High competition among generic manufacturers compresses margins but ensures steady revenue streams.


Sources:

[1] GlobalData, "Corticosteroids Market Report," 2022.
[2] FDA, "Approved Drug Products with Therapeutic Equivalence Evaluations," 2022.
[3] IHS Markit, "Pharmaceutical Manufacturing Capacity Database," 2022.
[4] PatentScope, WIPO, "Patent landscape for corticosteroids," 2023.
[5] MarketsandMarkets, "Inhalation Therapy Market," 2022.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.