Methylprednisolone - Generic Drug Details

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

Methylprednisolone is the generic ingredient in eleven branded drugs marketed by Pfizer, Amneal, Chartwell Rx, Duramed Pharms Barr, Endo Operations, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Pharmacia And Upjohn, Bel Mar, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in ninety-two NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for methylprednisolone. Thirty suppliers are listed for this compound.

Summary for methylprednisolone

US Patents:	0
Tradenames:	11
Applicants:	35
NDAs:	92
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	830
Patent Applications:	7,316
Drug Prices:	Drug price trends for methylprednisolone
Drug Sales Revenues:	Drug sales revenues for methylprednisolone
What excipients (inactive ingredients) are in methylprednisolone?	methylprednisolone excipients list
DailyMed Link:	methylprednisolone at DailyMed

See drug prices for methylprednisolone

See drug sales revenues for methylprednisolone

Recent Clinical Trials for methylprednisolone

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

Sponsor	Phase
University Hospital, Antwerp	Phase 3
Kasr El Aini Hospital	N/A
Hospital General Universitario de Alicante	Phase 4

See all methylprednisolone clinical trials

Pharmacology for methylprednisolone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for methylprednisolone

Anti-Inflammatory Agents

Antiemetics

Glucocorticoids

Neuroprotective Agents

Anatomical Therapeutic Chemical (ATC) Classes for methylprednisolone

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
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

US Patents and Regulatory Information for methylprednisolone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	202691-001	Feb 16, 2016	AP	RX	No	No
Chartwell Rx	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	209097-005	Feb 22, 2019		DISCN	No	No
Tianjin Kingyork	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	212396-005	Apr 20, 2021	AP	RX	No	No
Abraxis Pharm	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	089144-001	Mar 28, 1986		DISCN	No	No
Elkins Sinn	METHYLPREDNISOLONE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	086906-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Wilshire Pharms Inc	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	214870-002	May 10, 2023	AB	RX	No	No

Methylprednisolone Market Analysis and Financial Projection Experimental

Methylprednisolone Market Dynamics and Financial Trajectory

Market Overview

The methylprednisolone market is poised for significant growth, driven by its widespread use as a corticosteroid and immunosuppressive drug. 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[1].

Geographical Segmentation

• North America: This region held a dominant market share in 2021, accounting for 34% of the market. The robust healthcare system and government incentives for drug research and development are key factors contributing to this dominance[1].
• Asia-Pacific: This region is expected to offer lucrative growth opportunities due to the increasing geriatric population and rising awareness about better medical conditions. India, in particular, has seen a significant increase in healthcare expenditure, up by 137% in 2021[1].

Market Segmentation by Indication

• Rheumatic Disorders: This segment is projected to be the fastest-growing, with a CAGR of 3.8% from 2022 to 2027. Factors such as old age, smoking, early-life exposure to smoking, and obesity contribute to the rise in rheumatic diseases, making this segment highly lucrative[1].
• Dermatology: Methylprednisolone is used to treat various dermatological conditions, including atopic dermatitis, contact dermatitis, and pemphigus vulgaris. These indications are significant contributors to the market growth[3].

Market Segmentation by Distribution Channel

• Offline Retail: Offline retail channels held the dominant market share in 2021 due to the immediate need for treatments in emergency settings such as hospitals. However, online retail is expected to grow at a CAGR of 4.0% from 2022 to 2027, driven by strategies like memberships, cashback, and discounts offered by new market entrants[1].

Drivers of Market Growth

• Growing Prevalence of Auto-Immune Disorders: The increasing incidence of auto-immune disorders has significantly aided market growth. Conditions such as rheumatoid arthritis, lupus, and multiple sclerosis require methylprednisolone for management and treatment[1].
• Geriatric Population: The rising geriatric population globally is another key driver, as older adults are more prone to conditions that require corticosteroid treatment[1].

Challenges and Restraints

• Side Effects: Despite its efficacy, methylprednisolone is associated with several side effects, including hyperglycemia, hypertension, peptic ulcer, osteoporosis, and hidden infections. These side effects can hamper market growth[1][3].
• Environmental Factors: Changing environmental conditions that induce pathogen-related skin disorders also contribute to market growth but can be a double-edged sword due to the potential for increased side effects[1].

Financial Performance and Projections

• Revenue Growth: The methylprednisolone market is expected to see steady revenue growth, reaching $917.4 million by 2027. This growth is supported by the increasing demand for the drug across various indications[1].
• Regional Revenue: North America, while dominant, will continue to see significant revenue, while Asia-Pacific is expected to emerge as a key growth region. Countries like India are investing heavily in healthcare, which will drive market expansion[1].

Competitive Landscape

• Key Players: Major pharmaceutical companies, including Pfizer, are significant players in the methylprednisolone market. These companies are adopting various strategies such as discounts and membership plans to enhance market penetration[1][4].
• Market Entry and Expansion: New market entrants are devising innovative strategies to capture market share, including online retail and subscription models. This competitive landscape is expected to drive growth and innovation in the market[1].

Pharmacological and Clinical Aspects

• Pharmacokinetics: Methylprednisolone exhibits rapid and linear absorption, with peak concentrations achieved within 48 minutes of administration. Its oral bioavailability is approximately 88%, making it an effective treatment option[3].
• Clinical Applications: The drug is used across multiple fields due to its anti-inflammatory and immunosuppressive properties. Interprofessional healthcare teams play a crucial role in managing its use and monitoring for adverse effects[3].

Healthcare Team Outcomes

• Interprofessional Collaboration: Effective use of methylprednisolone requires collaboration among healthcare professionals, including nurses, pharmacists, and physicians. This ensures optimal therapeutic outcomes and minimizes adverse effects[3].

Key Takeaways

• The methylprednisolone market is expected to grow significantly, driven by increasing demand for treatments of auto-immune and inflammatory disorders.
• North America currently dominates the market, but Asia-Pacific is emerging as a key growth region.
• Online retail channels are expected to grow rapidly due to innovative marketing strategies.
• Side effects associated with methylprednisolone remain a significant challenge that needs to be managed through interprofessional healthcare collaboration.

Frequently Asked Questions (FAQs)

1. What are the primary indications for methylprednisolone? Methylprednisolone is used to treat a variety of conditions, including allergic reactions, arthritis, dermatological disorders, and endocrine conditions[3].

2. Which region is expected to offer the most growth opportunities for the methylprednisolone market? Asia-Pacific is set to offer lucrative growth opportunities due to the rising geriatric population and increasing awareness about better medical conditions[1].

3. What are the major side effects associated with methylprednisolone? Common side effects include hyperglycemia, hypertension, peptic ulcer, osteoporosis, and hidden infections[1][3].

4. How does the distribution channel impact the methylprednisolone market? Offline retail currently dominates, but online retail is growing rapidly due to strategies like memberships, cashback, and discounts[1].

5. What role does interprofessional collaboration play in the use of methylprednisolone? Interprofessional collaboration among healthcare professionals is crucial for managing the drug's use, monitoring for adverse effects, and ensuring optimal therapeutic outcomes[3].

Cited Sources:

1. IndustryARC, "Methylprednisolone Market - Forecast(2024 - 2030) - IndustryARC"
2. Sanofi, "Press Release Q4 2021 English"
3. NCBI Bookshelf, "Methylprednisolone - StatPearls"
4. Market Research Intellect, "Global Methylprednisolone Sodium Succinate Market Size, Trends ..."