REPATHA Drug Profile

Summary for Tradename: REPATHA

High Confidence Patents:	11
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for REPATHA
Recent Clinical Trials:	See clinical trials for REPATHA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REPATHA

See drug prices for REPATHA

Recent Clinical Trials for REPATHA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
Hamad Medical Corporation	Phase 4
Colorado Prevention Center	Phase 4

See all REPATHA clinical trials

Recent Litigation for REPATHA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Baxalta Incorporated v. Genentech, Inc.	2022-02-10
Amgen Inc. v. Sanofi	2017-01-11
Amgen Inc. v. Sanofi	2014-11-16

See all REPATHA litigation

Pharmacology for REPATHA

Mechanism of Action	PCSK9 Inhibitors
Established Pharmacologic Class	PCSK9 Inhibitor
Chemical Structure	Antibodies, Monoclonal

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. General brand-side disclosures

These patents were identified from searching 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 REPATHA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for REPATHA Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2027-08-23	Company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2027-08-23	Company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2027-08-23	Company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2027-08-23	Company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2027-08-23	Company disclosures

3) Low Certainty: US Patents for REPATHA 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
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2032-10-22	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2037-07-03	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2035-10-12	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2037-01-12	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2038-10-30	Patent claims search

International Patents for REPATHA

Country	Patent Number	Estimated Expiration
Finland	3666797
Poland	2215124
South Korea	20200074262
Australia	2013203689
Japan	2020058376

Supplementary Protection Certificates for REPATHA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2016 00037	Denmark		PRODUCT NAME: ALIROCUMAB; REG. NO/DATE: EU/1/15/1031 20150925
2016C/030	Belgium		PRODUCT NAME: EVOLOCUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1016 20150721
26/2016	Austria		PRODUCT NAME: EVOLOCUMAB; REGISTRATION NO/DATE: EU/1/15/1016 (MITTEILUNG) 20150721
93096	Luxembourg		PRODUCT NAME: EVOLOCUMAB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (REPATHA ); AUTHORISATION NUMBER AND DATE: EU/1/15/1016 - REPATHA - EVOLOCUMAB; 2015-07-21
CA 2016 00027	Denmark		PRODUCT NAME: EVOLOCUMAB; REG. NO/DATE: EU/1/15/1016 20150721

REPATHA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Repatha

Introduction

Repatha, a PCSK9 inhibitor developed by Amgen, has been a significant player in the cardiovascular drug market since its approval. Here, we will delve into the market dynamics and financial trajectory of Repatha, exploring its current status, future projections, and the factors influencing its success.

What is Repatha?

Repatha, also known as evolocumab, is a monoclonal antibody that targets PCSK9 (proprotein convertase subtilisin/kexin type 9), a protein involved in the regulation of cholesterol levels. By inhibiting PCSK9, Repatha reduces the amount of low-density lipoprotein (LDL) cholesterol, often referred to as "bad" cholesterol, in the blood.

Market Performance

Current Market Value

As of the latest reports, the global PCSK9 inhibitors market, led by Repatha, is estimated to be valued at around $3 billion. This market is projected to expand significantly, reaching a value of $13 billion by 2033, with Repatha expected to hold the largest market share during this period[1].

Regional Growth

The market for PCSK9 inhibitors, including Repatha, is anticipated to grow at varying rates across different regions. North America is expected to grow at a CAGR of 15.7%, Europe at 15.3%, and Asia Pacific at 15%. The Asia Pacific region is particularly noteworthy due to increased healthcare awareness, research activities, and government initiatives[1].

Financial Trajectory

Revenue Growth

Repatha has shown robust revenue growth. In 2018, Repatha generated $550 million in revenue, which increased by 20% to $661 million in the following year[3]. More recently, Repatha sales have continued to surge, with a 25% year-over-year increase in the fourth quarter of 2023, driven by 35% volume growth, though partially offset by lower net selling prices[5].

Quarterly and Annual Financials

Amgen's financial reports highlight the significant contribution of Repatha to the company's overall revenue. For the second quarter of 2024, Amgen's total revenues increased by 20% to $8.4 billion, with product sales, including Repatha, playing a crucial role. For the full year 2023, Repatha sales increased by 26%, driven by 37% volume growth[2][5].

Competitive Landscape

Challenges Faced by Other PCSK9 Inhibitors

Repatha's success stands in contrast to other PCSK9 inhibitors like Sanofi's Praluent. Despite their clinical efficacy, these drugs have faced commercial challenges. Praluent's revenues were underwhelming, with $308 million in 2018 and a decline to $283 million the following year, largely due to higher rebates and pricing issues[3].

Entry of New Competitors

The entry of new drugs, such as Novartis's inclisiran, is expected to impact the market dynamics. However, the success of these new entrants will depend on factors like pricing strategies and market access. As noted by Judy Sulick, VP of trade relations at EnvisionRx, "drugmakers are willing to leverage drug cost to optimize market access where clinical considerations are relatively similar"[3].

Pricing and Market Access

Pricing Strategies

The pricing of PCSK9 inhibitors has been a critical factor in their market performance. Repatha's pricing has been adjusted over time to optimize market access. The lessons learned from the pricing showdown between Repatha and Praluent indicate that drugmakers must carefully balance clinical value with cost considerations to achieve market success[3].

Research and Development

Future Innovations

Amgen is investing heavily in research and development, with a 25% increase in R&D spending in 2023. This investment is aimed at future breakthroughs, including potential weight-loss and cancer treatments. While Repatha remains a cornerstone of Amgen's portfolio, the company's R&D efforts are geared towards expanding its therapeutic offerings[4].

Market Projections

Growth Projections

The global PCSK9 inhibitors market, driven by Repatha, is projected to grow at a CAGR of 15.8% from 2023 to 2033. This growth is expected to be fueled by increasing healthcare awareness, government initiatives, and the expanding need for effective cholesterol management therapies[1].

Key Takeaways

• Market Leadership: Repatha is expected to hold the largest market share among PCSK9 inhibitors.
• Revenue Growth: Repatha has shown significant revenue growth, with a 25% year-over-year increase in the fourth quarter of 2023.
• Regional Expansion: The Asia Pacific region is expected to contribute substantially to the market growth due to increased healthcare awareness and government initiatives.
• Competitive Landscape: Repatha's success contrasts with the commercial challenges faced by other PCSK9 inhibitors like Praluent.
• Pricing Strategies: Careful pricing is crucial for optimizing market access and balancing clinical value with cost considerations.

FAQs

What is the current market value of the PCSK9 inhibitors market led by Repatha?

The global PCSK9 inhibitors market is estimated to be valued at around $3 billion[1].

How is the market for PCSK9 inhibitors expected to grow?

The market is projected to grow at a CAGR of 15.8% from 2023 to 2033, reaching a value of $13 billion by 2033[1].

Which region is expected to have the most significant market share for PCSK9 inhibitors?

Asia Pacific is expected to have a significant market share due to increased healthcare awareness, research activity, and government initiatives[1].

What are the main challenges faced by other PCSK9 inhibitors like Praluent?

Other PCSK9 inhibitors have faced commercial challenges, including higher rebates and pricing issues, leading to underwhelming revenues[3].

How is Amgen investing in the future of Repatha and other therapies?

Amgen is investing heavily in research and development, with a 25% increase in R&D spending in 2023, aimed at future breakthroughs in weight-loss and cancer treatments[4].

Sources

1. Future Market Insights Inc. - PCSK9 Inhibitors Market Sales to expand at a 15.8% CAGR from 2023 to 2033, Repatha-based Inhibitors to be Most Widely Used[1].
2. Amgen - AMGEN REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS[2].
3. MM+M - Can the third PCSK9 drug succeed where the first two failed?[3].
4. Finimize - Amgen Shines With Earnings Boost From Repatha And Prolia[4].
5. Amgen - AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS[5].