REBINYN Drug Profile

Summary for Tradename: REBINYN

High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 REBINYN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,138,371	2021-10-10	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,416,858	2040-03-31	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	7,473,680	2021-11-28	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	8,404,809	2029-10-23	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	8,632,770	2030-08-06	Company disclosures
Novo Nordisk Inc.	REBINYN	coagulation factor ix (recombinant), glycopegylated	For Injection	125611	8,791,070	2033-10-11	Company disclosures

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

No patents found based on company disclosures

International Patents for REBINYN

Country	Patent Number	Estimated Expiration
Japan	5743368
Austria	E542915
Brazil	0213207
European Patent Office	1720892
Japan	5739632
Japan	2015110650

Supplementary Protection Certificates for REBINYN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122017000105	Germany		PRODUCT NAME: NONACOG BETA PEGOL; REGISTRATION NO/DATE: EU/1/17/1193 20170602
300912	Netherlands		PRODUCT NAME: NONACOG BETA PEGOL; REGISTRATION NO/DATE: EU/1/17/1193/001-003 20170607
608	Finland
132017000138764	Italy		PRODUCT NAME: NONACOG BETA PEGOL(REFIXIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1193, 20170607
C300638	Netherlands		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
2017/055	Ireland		PRODUCT NAME: NONACOG BETA PEGOL; REGISTRATION NO/DATE: EU/1/17/1193 20170607

REBINYN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Biologic Drug: REBINYN

Introduction to REBINYN

REBINYN, developed by Novo Nordisk, is a recombinant factor IX extended half-life therapy designed for the treatment of individuals with hemophilia B, a rare and life-threatening bleeding disorder. This drug is indicated for the on-demand treatment and control of bleeding episodes, management of bleeding around surgery, and routine prophylaxis to reduce the frequency of bleeding episodes[2][4].

Market Size and Growth Prospects

The hemophilia market, which includes therapies like REBINYN, is expected to grow significantly. The global hemophilia market is estimated to reach USD 17.86 billion by 2028, growing at a CAGR of 5.5% from 2024. This growth is driven by increasing cases of hemophilia and the development of new therapies[1].

Product Approvals and Clearances

Recent approvals and clearances have bolstered the market position of REBINYN. For instance, in October 2022, Health Canada approved REBINYN for routine prophylaxis in hemophilia B patients of all ages, including those under 18 years. This expanded indication has increased the drug's market potential[1].

Clinical Trials and Research

Novo Nordisk has been actively involved in clinical trials and research to enhance the efficacy and safety profile of REBINYN. The drug has demonstrated positive results in various studies, including a Phase 3 trial that showed its effectiveness in providing long-term bleed protection and resolving target joints in patients with hemophilia B[5].

Supply Chain and Demand Dynamics

Despite the positive market outlook, REBINYN is currently facing a temporary shortage of its 3,000 IU vial size due to unexpectedly high demand. This shortage is expected to result in an intermittent supply over the next couple of months. However, Novo Nordisk has assured that the overall supply of other vial sizes (500 IU, 1,000 IU, and 2,000 IU) will be maintained, allowing patients to use a combination of these strengths to achieve the necessary dose[2][4].

Financial Performance of Novo Nordisk

Novo Nordisk's financial performance is influenced by its diverse portfolio of biopharmaceuticals, including REBINYN. In the first quarter of 2019, the company reported a sales growth of 4%, driven primarily by the diabetes and obesity segments. However, the hemophilia segment, which includes REBINYN, experienced a slight decline. Despite this, the company's overall operating profit growth was 8%, driven by sales performance and other factors[3].

Competitive Landscape

The hemophilia market is highly competitive, with several key players including BioMarin, Sanofi, and Sobi. Novo Nordisk's position in this market is strengthened by its extensive research and development efforts, as well as its strong brand presence. The company's ability to maintain economies of scale and high barriers to entry in the biologics market also supports its financial trajectory[1][3].

Regional Market Share

North America is expected to register a significant market share for hemophilia therapies, including REBINYN, due to the increasing number of hemophilia cases and the rise in different therapies for the condition. Novo Nordisk's strong presence in this region, coupled with ongoing research and development, is likely to contribute to the drug's market success[1].

Patient Impact and Clinical Efficacy

REBINYN has shown significant clinical efficacy in treating hemophilia B. The drug's once-weekly administration delivers high Factor 9 activity, providing long-term bleed protection. Clinical trials have demonstrated that REBINYN can resolve target joints in a high percentage of patients, improving their quality of life[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of biologic drugs like REBINYN. Recent approvals and clearances, such as the Health Canada approval, highlight the favorable regulatory landscape. Additionally, designations like the FDA's Breakthrough Therapy designation for other hemophilia therapies indicate a supportive regulatory environment that can accelerate market access[1][3].

Financial Outlook

Novo Nordisk's financial outlook remains positive, with expected sales growth of 2-5% at constant exchange rates. The company's operating profit growth is targeted at 5% yearly on average, and it aims to convert earnings into cash at a rate of 85%. These financial targets are supported by the company's strong portfolio and ongoing research and development activities[3].

Challenges and Opportunities

While the temporary shortage of the 3,000 IU vial size of REBINYN poses a challenge, it also highlights the strong demand for the drug. This demand can be seen as an opportunity for Novo Nordisk to scale up production and meet the growing needs of patients with hemophilia B. Additionally, the company's ongoing research and development efforts can lead to further product enhancements and new indications, expanding the market potential of REBINYN[2][4].

Key Takeaways

• Market Growth: The hemophilia market, including REBINYN, is expected to grow at a CAGR of 5.5% from 2024 to 2028.
• Regulatory Approvals: Recent approvals, such as Health Canada's approval for REBINYN, have expanded its market potential.
• Clinical Efficacy: REBINYN has demonstrated significant clinical efficacy in treating hemophilia B, providing long-term bleed protection.
• Supply Chain: A temporary shortage of the 3,000 IU vial size is expected, but other vial sizes will be maintained.
• Financial Performance: Novo Nordisk's financial performance is strong, with targeted sales and operating profit growth.

FAQs

What is REBINYN used for?

REBINYN is used to treat, prevent, or reduce the frequency of bleeding episodes in people with hemophilia B. It is indicated for on-demand treatment, control of bleeding episodes, management of bleeding around surgery, and routine prophylaxis[2].

What is the current market size of the hemophilia market?

The global hemophilia market is estimated at USD 13.66 billion in 2024 and is expected to reach USD 17.86 billion by 2028[1].

Why is there a shortage of REBINYN 3,000 IU vials?

The shortage is due to unexpectedly high demand for the 3,000 IU vial size, which has outpaced Novo Nordisk's expectations[4].

How does REBINYN compare to other hemophilia therapies?

REBINYN offers once-weekly administration and extended half-life, providing long-term bleed protection. It has demonstrated significant clinical efficacy in resolving target joints in patients with hemophilia B[5].

What is Novo Nordisk's financial outlook for the coming years?

Novo Nordisk expects sales growth of 2-5% at constant exchange rates and operating profit growth of 5% yearly on average. The company aims to convert earnings into cash at a rate of 85%[3].

Sources

1. Mordor Intelligence: Hemophilia Market Size & Share Analysis - Industry Research Report
2. National Hemophilia Foundation: Vial Size Shortage for Hemophilia B Product
3. Novo Nordisk: Investor presentation First quarter of 2019
4. Hemophilia News Today: Monthslong shortage forecast for Rebinyn 3000 IU for hemophilia B
5. Novo Nordisk: ONCE-WEEKLY REBINYN® HELPS YOU KEEP FACTOR 9 ...