MEDROL Drug Patent Profile

Which patents cover Medrol, and what generic alternatives are available?

Medrol is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in three NDAs.

The generic ingredient in MEDROL is methylprednisolone. There are forty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the methylprednisolone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Medrol

A generic version of MEDROL was approved as methylprednisolone by WATSON LABS on October 16^th, 1997.

Summary for MEDROL

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	129
Patent Applications:	4,788
Drug Prices:	Drug price information for MEDROL
What excipients (inactive ingredients) are in MEDROL?	MEDROL excipients list
DailyMed Link:	MEDROL at DailyMed

See drug prices for MEDROL

See drug sales revenues for MEDROL

Recent Clinical Trials for MEDROL

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

Sponsor	Phase
Vanderbilt University Medical Center	PHASE4
St. Louis University	PHASE4
Takeda	PHASE2

See all MEDROL clinical trials

Pharmacology for MEDROL

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for MEDROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	MEDROL	methylprednisolone acetate	ENEMA;RECTAL	018102-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153-006	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153-004	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Pharmacia And Upjohn	MEDROL ACETATE	methylprednisolone acetate	OINTMENT;TOPICAL	012421-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153-002	Approved Prior to Jan 1, 1982		RX	Yes	No
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153-005	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for MEDROL

Last updated: February 10, 2026

Current Market Position and Usage

Medrol (methylprednisolone) is a corticosteroid used primarily to suppress immune response and reduce inflammation. It is prescribed for conditions such as arthritis, allergic reactions, and certain autoimmune diseases. Medrol is marketed by Pfizer, with formulations including tablets and injectable forms.

Market Share and Competitive Landscape

• Market Size: The global corticosteroids market was valued at approximately $4.5 billion in 2021. Medrol accounts for a significant share within the oral corticosteroids segment due to its established brand presence.
• Competitors: Key competitors include Prednisolone (Bausch Health), Deltasone (Pfizer), and generic methylprednisolone products. The generic segment has gained prominence due to patent expirations.
• Market Share Trends: Pfizer's Medrol maintains a stable share among branded corticosteroids but faces increasing competition from generics, especially in mature markets like the US and Europe.

Pricing Dynamics

• Price Trends: The retail price of Medrol varies by region, with US prices around $2–$3 per tablet for a standard dose. Generics sell at a 50–70% discount, intensifying price competition.
• Reimbursement and Insurance: US reimbursement policies favor generics, pressuring branded medication pricing.

Regulatory Environment and Patent Status

• Patent Landscape: Pfizer's US patent for Medrol expired in 2018, enabling generic manufacturing. No current patent protections are active for the branded formulation in key markets.
• Regulatory Changes: Strict regulations on corticosteroid prescriptions and increasing scrutiny on off-label uses influence market dynamics.

Financial Trajectory and Revenue Projections

• Historical Revenue: Pfizer's corticosteroids segment, including Medrol, generated approximately $1.1 billion in global sales in 2019. Post-patent expiry, revenues declined sharply, with current estimates around $300 million annually.
• Impact of Generics: Revenue decline due to generic competition is expected to continue, with projections showing a 10–15% annual decrease over the next five years.
• Market Growth Potential: Limited growth prospects exist; the market is mature, with slow annual growth rates of about 1–2%. The primary opportunity lies in expanding into emerging markets and biosimilar developments.

Emerging Opportunities and Risks

• Potential Biosimilar Development: Biosimilar corticosteroids are under development, aiming to reduce costs and expand access.
• Risks: Patent litigations, regulatory delays, and pricing pressures from healthcare systems present ongoing challenges. The COVID-19 pandemic temporarily increased corticosteroid use but did not significantly alter long-term market trends.

Summary of Financial Forecasts

Year	Estimated Global Sales	Growth Rate	Key Factors
2022	$300 million	-10%	Continued generic market penetration
2025	$255 million	-15% annual	Patent expiry impact persists
2030	<$200 million	N/A	Market saturation, limited innovation

Key Takeaways

• Medrol's market share is predominantly affected by patent expirations and price competition from generics.
• Revenue has declined substantially since 2018, with limited prospects for significant growth.
• The overall corticosteroid market is mature, growing slowly, with potential in biosimilars and emerging markets.
• Pfizer's future revenue from Medrol relies on strategic diversification and biosimilar pipeline development amid patent cliffs.

FAQs

1. What caused the decline in Medrol's revenue? Patent expiration in 2018 allowed generics to enter the market, driving prices down and reducing Pfizer's market share.
2. Are there any patent protections remaining for Medrol? No; Pfizer's patents expired, enabling generic competition.
3. What are the main competitors to Medrol? Generic methylprednisolone products and other corticosteroids like Prednisolone.
4. Is there room for growth in the corticosteroid market? Growth is limited; the market is mature with slow expansion primarily in emerging markets.
5. What future developments could affect Medrol's market? Biosimilar corticosteroids, regulatory changes, and pricing policies could influence the landscape.

References

[1] MarketWatch. “Corticosteroids Market Size, Share, Trends & Forecasts,” 2022.
[2] Pfizer’s Annual Report 2021.
[3] EvaluatePharma. “Global Corticosteroids Market 2021-2031,” 2022.