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Last Updated: December 22, 2024

METHYLPREDNISOLONE ACETATE Drug Patent Profile


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Which patents cover Methylprednisolone Acetate, and what generic alternatives are available?

Methylprednisolone Acetate is a drug marketed by Amneal, Endo Operations, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc. and is included in seventeen NDAs.

The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Methylprednisolone Acetate

A generic version of METHYLPREDNISOLONE ACETATE was approved as methylprednisolone acetate by HONG KONG on February 23rd, 2005.

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Drug patent expirations by year for METHYLPREDNISOLONE ACETATE
Drug Prices for METHYLPREDNISOLONE ACETATE

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Drug Sales Revenue Trends for METHYLPREDNISOLONE ACETATE

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Recent Clinical Trials for METHYLPREDNISOLONE ACETATE

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SponsorPhase
Menoufia UniversityN/A
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
Yale UniversityPhase 2

See all METHYLPREDNISOLONE ACETATE clinical trials

Pharmacology for METHYLPREDNISOLONE ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for METHYLPREDNISOLONE ACETATE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for METHYLPREDNISOLONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wilshire Pharms Inc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 214870-002 May 10, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wilshire Pharms Inc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 214870-001 Jan 3, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 210043-001 May 20, 2019 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040719-002 Jan 29, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 085374-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 086903-001 Oct 20, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 216502-002 Nov 3, 2023 AB RX No 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

METHYLPREDNISOLONE ACETATE Market Analysis and Financial Projection Experimental

Methylprednisolone Acetate Market Dynamics and Financial Trajectory

Market Overview

Methylprednisolone acetate, a derivative of prednisolone, is a widely used corticosteroid with immunosuppressive properties. The global market for methylprednisolone acetate is driven by several key factors, including the increasing prevalence of autoimmune and inflammatory disorders.

Market Size and Growth

The methylprednisolone market is projected to grow significantly over the forecast period. By 2027, the market size is estimated to reach $917.4 million, growing at a Compound Annual Growth Rate (CAGR) of 3.4% from 2022 to 2027[4].

Segmentation Analysis

By Product Type

The market is segmented into infusion type and oral type. The infusion type, particularly the injectable suspension, is widely used for intramuscular administration and is a significant segment due to its efficacy in treating various conditions such as dermatologic lesions, rheumatic disorders, and allergic conditions[3][5].

By Application

The market is categorized into medical and research & development (R&D) applications. The medical segment dominates due to the drug's use in treating a range of conditions including rheumatic disorders, asthma, systemic lupus erythematosus, allergic conditions, eye disorders, and skin disorders[3][4].

By Distribution Channel

The market is segmented into offline and online retail. Offline retail held a dominant market share in 2021, primarily due to the immediate need for treatment in emergency settings. However, the online segment is expected to grow at a CAGR of 4.0% over the forecast period, driven by strategies such as memberships, cashback, and discounts[4].

By Geography

Geographically, the market is analyzed across North America, Europe, Asia-Pacific, and other regions. North America held a dominant market share in 2021, attributed to the robust healthcare infrastructure and high prevalence of conditions such as obesity. However, the Asia-Pacific region is expected to offer lucrative growth opportunities due to the increasing geriatric population and rising awareness of better medical conditions[4].

Key Drivers

  • Growing Prevalence of Autoimmune Disorders: The increasing incidence of autoimmune and inflammatory disorders is a major driver of the methylprednisolone acetate market. Conditions such as rheumatic disorders, asthma, and skin disorders are becoming more prevalent, driving the demand for corticosteroids like methylprednisolone acetate[4].
  • Geriatric Population: The growing geriatric population is another significant factor, as older individuals are more prone to immune disorders and other conditions that require corticosteroid treatment[4].
  • Government Incentives: Government incentives for research and development in the healthcare sector, particularly in regions like North America, also contribute to market growth[4].

Market Challenges

  • Side Effects: The use of corticosteroids like methylprednisolone acetate is associated with several side effects, which can hamper market growth. These side effects include systemic fungal infections, hypersensitivity reactions, and other adverse effects such as septic arthritis when used intra-synovially[2][4].
  • Regulatory Hurdles: The approval process for new formulations and dosages can be stringent, which may slow down market expansion. However, bioequivalence studies, such as those conducted for Sandoz's methylprednisolone acetate injectable suspension, help in ensuring therapeutic equivalence to existing products[5].

Market Prices

The prices of methylprednisolone acetate vary by region. In Europe, Asia, and North America, the prices are influenced by factors such as production costs, market demand, and regulatory environments. For instance, the price of Depo-Medrol (methylprednisolone acetate) can vary significantly depending on the region and the specific formulation (e.g., 40 mg/mL or 80 mg/mL)[1][4].

Manufacturers and Suppliers

The market includes several key manufacturers such as Pfizer Inc., Sandoz, Jubilant Cadista, Teva Pharmaceuticals, and Tianjin Kingyork. These companies operate globally and have a significant presence in regions like North America, Europe, and Asia-Pacific. Suppliers and distributors play a crucial role in ensuring the availability of the drug across different markets[1][3][4].

End-Use Sector

Methylprednisolone acetate is used in various therapeutic areas, including:

  • Rheumatic Disorders: This segment is expected to be the fastest-growing, driven by the rise in risk factors such as old age, smoking, and obesity[4].
  • Asthma and Allergic Conditions: The drug is effective in managing asthma and other allergic conditions, contributing to its market demand.
  • Skin Disorders: Methylprednisolone acetate is used to treat dermatologic lesions and other skin conditions, further expanding its market scope[2][4].

Market Forecast

The market forecast indicates a positive trajectory, driven by the increasing demand for corticosteroids and the expanding geriatric population. The Asia-Pacific region is expected to offer significant growth opportunities due to rising healthcare expenditure and increasing awareness of better medical conditions[4].

Key Takeaways

  • The methylprednisolone acetate market is projected to reach $917.4 million by 2027.
  • The market is driven by the growing prevalence of autoimmune and inflammatory disorders.
  • North America currently holds a dominant market share, but the Asia-Pacific region is expected to grow rapidly.
  • The drug is used in various therapeutic areas, including rheumatic disorders, asthma, and skin disorders.
  • Side effects and regulatory hurdles are key challenges facing the market.

Frequently Asked Questions (FAQs)

Q: What is the primary use of methylprednisolone acetate? A: Methylprednisolone acetate is primarily used as a corticosteroid to treat various conditions such as rheumatic disorders, asthma, systemic lupus erythematosus, allergic conditions, eye disorders, and skin disorders.

Q: Which region dominates the methylprednisolone acetate market? A: North America currently holds a dominant market share, but the Asia-Pacific region is expected to offer significant growth opportunities in the future.

Q: What are the key drivers of the methylprednisolone acetate market? A: The key drivers include the growing prevalence of autoimmune and inflammatory disorders, the increasing geriatric population, and government incentives for healthcare research and development.

Q: What are the common side effects associated with methylprednisolone acetate? A: Common side effects include systemic fungal infections, hypersensitivity reactions, and other adverse effects such as septic arthritis when used intra-synovially.

Q: Who are the major manufacturers of methylprednisolone acetate? A: Major manufacturers include Pfizer Inc., Sandoz, Jubilant Cadista, Teva Pharmaceuticals, and Tianjin Kingyork.

Cited Sources:

  1. METHYLPREDNISOLONE ACETATE (CAS 53-36-1) Market Research Report 2024 - MarketPublishers.
  2. METHYLPREDNISOLONE ACETATE - Pfizer.
  3. Methylprednisolone Market - Allied Market Research.
  4. Methylprednisolone Market - Forecast(2024 - 2030) - IndustryARC.
  5. Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL - FDA.

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