PLEGRIDY Drug Profile

Summary for Tradename: PLEGRIDY

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for PLEGRIDY

Recent Clinical Trials for PLEGRIDY

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Holy Name Medical Center, Inc.	Phase 4
Biogen	Phase 4
New York University School of Medicine	Phase 4

See all PLEGRIDY clinical trials

Pharmacology for PLEGRIDY

Established Pharmacologic Class	Interferon beta
Chemical Structure	Interferon-beta

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for PLEGRIDY Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PLEGRIDY Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	7,446,173	2024-03-16	DrugPatentWatch analysis and company disclosures
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	8,017,733	2024-07-16	DrugPatentWatch analysis and company disclosures
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	8,524,660	2031-09-12	DrugPatentWatch analysis and company disclosures
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	9,138,403	2028-12-18	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for PLEGRIDY Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	10,085,955	2034-01-08	Patent claims search
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	10,213,420	2036-10-04	Patent claims search
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	10,350,178	2038-08-23	Patent claims search
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	10,632,112	2038-12-28	Patent claims search
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	10,849,919	2038-11-23	Patent claims search
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	10,961,585	2039-08-15	Patent claims search
Biogen Inc.	PLEGRIDY	peginterferon beta-1a	Injection	125499	11,279,753	2039-11-22	Patent claims search

International Patents for PLEGRIDY

Country	Patent Number	Estimated Expiration
Brazil	PI0306993
China	101878043
Japan	2005526151
Cyprus	1112820
Georgia, Republic of	P20074024
Mexico	PA04006855
Slovenia	3025726

Supplementary Protection Certificates for PLEGRIDY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1690034-2	Sweden		PRODUCT NAME: PEGINTERFERON BETA-1 A; REG. NO/DATE: EU/1/14/934 20140723
2016C/040	Belgium		PRODUCT NAME: PEGINTERFERON BETA-1A; AUTHORISATION NUMBER AND DATE: EU/1/14/934 20140723
93162	Luxembourg		PRODUCT NAME: PEGINTERFERON BETA-1A OU UN DERIVE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PLEGRIDY); FIRST REGISTRATION DATE: 20140723
35/2016	Austria		PRODUCT NAME: PEGINTERFERON BETA-1A; REGISTRATION NO/DATE: EU/1/14/934 (MITTEILUNG) 20140723
CA 2016 00035	Denmark		PRODUCT NAME: PEGINTERFERON BETA-1A ELLER ET BIOSIMILAERT PRODUKT IFOELGE ARTIKEL 10(4) I DIREKTIV 2001/83/EC SOM BESKYTTET I GRUNDPATENTET; REG. NO/DATE: EU/1/14/934 20140723
16C0034	France		PRODUCT NAME: PEGINTERFERON BETA-1A; REGISTRATION NO/DATE: EU/1/14/934 20140723
300826	Netherlands		PRODUCT NAME: PEGINTERFERON BETA-1A; REGISTRATION NO/DATE: EU/1/14/934 20140723

Market Dynamics and Financial Trajectory for PLEGRIDY

Last updated: November 9, 2025

Introduction

Plegridy (peginterferon beta-1a) is a biologic disease-modifying therapy (DMT) approved by the U.S. Food and Drug Administration (FDA) in 2014 for multiple sclerosis (MS) management. As a pegylated interferon beta-1a formulation, Plegridy offers extended dosing intervals compared to traditional interferons, potentially improving patient adherence and quality of life. Its market trajectory is shaped by evolving MS treatment paradigms, competitive dynamics within biologics and immunomodulators, regulatory developments, and the broader biotech landscape.

Market Overview of Multiple Sclerosis Therapies

Multiple sclerosis affects approximately 2.8 million individuals worldwide, representing a lucrative segment for biopharmaceutical innovation. The MS therapeutics market is projected to reach $30 billion globally by 2025, driven by increasing diagnosis rates, expanding treatment indications, and enhanced biologic options [1].

The therapeutic landscape includes injectable immunomodulators, oral agents, and recently introduced infusion therapies. Among these, interferons such as Plegridy have traditionally formed the backbone of MS management, especially for relapsing-remitting MS (RRMS).

Market Dynamics Influencing Plegridy

Growing Preference for Extended-Dosing Regimens

Plegridy's pegylation prolongs the half-life of interferon beta-1a, enabling dosing every two weeks versus the weekly schedule necessary for earlier formulations. This extended dosing reduces injection frequency, addressing patient compliance issues—a critical determinant in treatment success [2]. As convenience becomes a priority, Plegridy’s formulation aligns with patient-centric care trends, bolstering its market appeal.

Competitive Landscape and Substitutes

Despite its advantages, Plegridy faces significant competition from multiple MS agents:

• Other Interferon Beta Products: Avonex (interferon beta-1a, weekly), Rebif (interferon beta-1a, thrice weekly)
• Oral Therapies: Oral DMTs like Tecfidera (dimethyl fumarate), Mavenclad (cladribine), and Aubagio (teriflunomide) offer easier administration and have gained favor among some patient subsets.
• Monoclonal Antibodies: Ocrevus (ocrelizumab), Lemtrada (alemtuzumab), and Mavenclad offer high efficacy for progressive and relapsing forms but at increased cost and safety concerns.

This competitive environment pressures Plegridy's market share, especially as oral and monoclonal antibody options improve in efficacy and safety profiles.

Pricing and Reimbursement Dynamics

Plegridy's pricing reflects its biologic complexity, with costs estimated between $47,000 to $60,000 annually per patient [3]. Payers scrutinize cost-effectiveness, favoring oral agents and biosimilars when available. Nonetheless, Plegridy's established safety profile and extended dosing may justify premium pricing in certain healthcare settings.

Reimbursement landscape remains complex, influenced by formulary inclusion, payor policies, and regional healthcare economics. The expansion of value-based reimbursement models could pressure prices but also incentivize adherence, indirectly benefiting Plegridy's market presence.

Regulatory and Patent Considerations

Patent protections for Plegridy extend into the late 2020s, safeguarding exclusivity and preventing biosimilar entry. However, upcoming patent cliffs or biosimilar developments could reshape the competitive landscape. Regulatory agencies' stance on biosimilars and interchangeability can influence market penetration, impacting Plegridy’s long-term financial trajectory.

Market Penetration and Adoption Trends

Plegridy has achieved moderate penetration within the MS treatment arena, favored for its convenience and tolerability. The practitioner community's familiarity with interferons and the inertia of established treatments influence adoption rates. Yet, increasing clinician confidence in newer agents and patient preferences for oral options may limit growth.

Financial Trajectory and Revenue Projections

Historical Revenue Performance

Since its launch, Plegridy has demonstrated steady revenue growth, with estimates approaching $400 million in the U.S. market by 2022 [4]. Growth rates have plateaued slightly due to competitive pressures but remain resilient owing to its differentiation and clinical profile.

Forecasted Growth and Revenue Streams

Projections suggest a compound annual growth rate (CAGR) of approximately 3-5% over the next five years, contingent upon several factors:

• Pipeline and Line Extensions: No current Plegridy-specific line extensions are announced, but ongoing development of biosimilars and combination therapies could impact revenues.
• Market Expansion: Increasing global adoption, particularly in emerging markets with expanding healthcare infrastructure, could provide incremental growth.
• Pricing Adjustments: Cost management strategies and payor negotiations may influence net revenue.

Potential Challenges

• Biosimilar Threats: The development of biosimilar interferons is imminent in multiple jurisdictions, threatening to erode Plegridy’s market share and revenue.
• SHALE (Shift in Treatment Paradigm): A pivot towards oral or high-efficacy monoclonal antibody therapies might suppress demand.

Strategic Considerations

Manufacturers aim to reinforce Plegridy’s value proposition through differentiating clinical data, safety profiles, and patient adherence benefits. Strategic collaborations and indications expansion, such as progressive MS management, could unlock additional revenues.

Regulatory Trends and Future Outlook

Regulatory agencies are increasingly emphasizing real-world evidence to support drug utilization, safety, and efficacy. The FDA’s encouragement of biosimilar approvals could accelerate competition. Continued patent protections and regulatory exclusivity remain crucial for Plegridy's financial outlook.

In summary, Plegridy’s future hinges on its ability to maintain differentiation amidst a dynamic MS therapy landscape, leveraging its extended dosing schedule and established safety profile while navigating biosimilar threats and evolving treatment algorithms.

Key Takeaways

• Market Position: Plegridy benefits from dosing convenience and a strong safety record, maintaining a niche within evolving MS therapies.
• Competitive Challenges: The rise of oral DMTs and monoclonal antibodies, coupled with biosimilar entrants, pose significant threats to its market share and revenue.
• Financial Outlook: Revenue growth is modest but steady, supported by global expansion and brand loyalty, yet vulnerable to pricing pressures and biosimilar competition.
• Regulatory and Patent Environment: Patent protections prolong exclusivity, but biosimilar approvals and regulatory shifts could impact future profitability.
• Strategic Focus: To sustain financial trajectory, manufacturers must emphasize differentiating clinical benefits, explore expansion into new indications, and enhance patient adherence strategies.

FAQs

1. What distinguishes Plegridy from other MS biologics?
Plegridy’s pegylation extends its half-life, allowing biweekly dosing, which reduces injection frequency and improves patient adherence compared to traditional interferons.

2. How do biosimilars threaten Plegridy’s market share?
Biosimilars, developed to be highly similar to Plegridy, could enter the market at lower prices, diminishing revenue and market dominance unless Plegridy maintains a competitive advantage through differentiators or additional indications.

3. What are the key factors influencing Plegridy’s revenues?
Market penetration, competitive landscape, pricing strategies, payer reimbursement policies, and regulatory changes predominantly impact revenues.

4. Is Plegridy likely to expand into other indications?
While primarily approved for RRMS, ongoing research into interferon-based therapies could support additional MS subtypes or autoimmune conditions, but such expansions depend on clinical validation and regulatory approval.

5. How does the current MS treatment landscape impact Plegridy’s future?
The emergence of oral agents and high-efficacy monoclonal antibodies shifts treatment preferences. Plegridy must compete by emphasizing adherence benefits, safety, and possibly combination therapies to sustain its market share.

References

1. Global Multiple Sclerosis Therapeutics Market Analysis, Q4 2022.
2. Patient adherence and extended dosing schedules for MS therapies, Neurology Today, 2021.
3. Average Wholesale Price (AWP) of Plegridy, 2022.
4. Company financial reports and market analyses, 2022.