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ORLADEYO Drug Patent Profile

Which patents cover Orladeyo, and when can generic versions of Orladeyo launch?

Orladeyo is a drug marketed by Biocryst and is included in one NDA. There are eight patents protecting this drug.

This drug has eighty-one patent family members in thirty-four countries.

The generic ingredient in ORLADEYO is berotralstat hydrochloride. One supplier is listed for this compound. Additional details are available on the berotralstat hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Orladeyo

Orladeyo was eligible for patent challenges on December 3, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 1, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ORLADEYO

International Patents:	81
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	1
Patent Applications:	3
Drug Prices:	Drug price information for ORLADEYO
What excipients (inactive ingredients) are in ORLADEYO?	ORLADEYO excipients list
DailyMed Link:	ORLADEYO at DailyMed

See drug prices for ORLADEYO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORLADEYO

Constraining patent/regulatory exclusivity:

10,662,160

NDA:

214094

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ORLADEYO

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

Sponsor	Phase
BioCryst Pharmaceuticals	Phase 3

See all ORLADEYO clinical trials

Pharmacology for ORLADEYO

Drug Class	Plasma Kallikrein Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Kallikrein Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ORLADEYO

ORLADEYO is protected by eight US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,662,160.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	11,117,867		Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes	10,329,260			Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	11,618,733
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	10,125,102			Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes	11,230,530
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes

International Patents for ORLADEYO

When does loss-of-exclusivity occur for ORLADEYO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Peru

Philippines

Singapore

South Korea

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORLADEYO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2022259742
Spain	2932406
Lithuania	3828173
Eurasian Patent Organization	036251	ИНГИБИТОРЫ КАЛЛИКРЕИНА ПЛАЗМЫ ЧЕЛОВЕКА (HUMAN PLASMA KALLIKREIN INHIBITORS)
Israel	280785
New Zealand	762034

Supplementary Protection Certificates for ORLADEYO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3113772	122021000062	Germany		PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	SPC/GB21/061	United Kingdom		PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/21/1544(FOR NI) 20210504; UK FURTHER MA ON IPSUM 20210504
3113772	CA 2021 00040	Denmark		PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	2190040-2	Sweden		PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	PA2021524	Lithuania		PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	21C1048	France		PRODUCT NAME: BEROTRALSTAT ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1544 20210504

ORLADEYO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ORLADEYO

Introduction to ORLADEYO

ORLADEYO, developed by BioCryst Pharmaceuticals, is a once-daily oral medication designed to prevent attacks of hereditary angioedema (HAE), a rare and potentially life-threatening genetic disorder. The drug has been making significant strides in the market, driven by its efficacy, convenience, and strong patient demand.

Revenue Growth and Market Performance

Quarterly Revenue Increases

ORLADEYO has consistently shown robust revenue growth. In the second quarter of 2024, the drug's net revenue increased by 34% year-over-year (y-o-y) to $108.3 million[1]. This trend continued into the third quarter, with a 35.7% y-o-y increase to $116.3 million[2][3].

Full-Year Revenue Projections

The strong quarterly performance has led to an upward revision in full-year revenue guidance. For 2024, BioCryst now expects ORLADEYO net revenue to be between $430-$435 million, up from the initial range of $380-$400 million[2][4].

Operational and Financial Highlights

Operating Profitability

BioCryst achieved a GAAP operating profit of $8.8 million in Q2 2024, a significant improvement from the loss incurred in Q2 2023. The non-GAAP operating profit was $21.9 million for the same period. In Q3 2024, the company reported a GAAP operating profit of $7.7 million and a non-GAAP operating profit of $24.9 million[1][2].

Expense Management

Research and Development (R&D) expenses decreased by 26.6% y-o-y to $37.6 million in Q2 2024, while Selling, General, and Administrative (SG&A) expenses increased by 20% y-o-y to $61.2 million. In Q3 2024, SG&A expenses rose further by 28.7% y-o-y to $65.1 million[1][2].

Cash Reserves and Financial Health

As of June 30, 2024, BioCryst's cash reserves totaled $338.1 million. By the end of Q3 2024, this figure had decreased to $351.7 million, still a healthy position given the company's operational needs[1][2].

Market Expansion and Patient Demand

Global Availability

ORLADEYO is now commercially available in more than 20 countries, including recent approvals and reimbursement authorizations in Europe and Latin America. Ex-U.S. revenue for ORLADEYO increased by 51% y-o-y in Q2 2024, contributing 11% to global net revenues[1].

Patient Retention and New Prescriptions

The drug has seen strong patient retention, with over 60% of patients staying on paid therapy for at least a year. New patient starts have maintained a high rate, similar to the initial launch period in 2021. The reimbursed product rate in the U.S. has also increased, reaching 74.8% by Q3 2024[1][3].

Prescriber Confidence

A recent market research study indicated that 52% of allergist/immunologists are extremely likely to prescribe ORLADEYO to more patients, up from 29% in early 2023. This increased confidence among prescribers is a key driver of the drug's commercial success[1].

Pipeline and Future Developments

Rare Disease Pipeline

BioCryst is building on the success of ORLADEYO by advancing other rare disease products. Notably, BCX17725 for Netherton syndrome is entering clinical trials, and avoralstat for diabetic macular edema is also in the pipeline[1][2].

Financial Outlook and Milestones

Path to Profitability

BioCryst expects to achieve full-year operating profit in 2024, excluding non-cash stock compensation. The company is also on track to approach quarterly positive earnings per share (EPS) and positive cash flow in the second half of 2025, and to be profitable on an EPS basis with positive cash flow for the full year 2026, all without additional fundraising[2][4].

Peak Sales Projections

Based on the established sales trajectory and durable patient demand, BioCryst is confident that ORLADEYO will reach peak sales of $1 billion. This projection is supported by the drug's real-world efficacy and the continued expansion of its global market presence[3][4].

Key Takeaways

• Robust Revenue Growth: ORLADEYO has shown consistent year-over-year revenue increases, with Q2 and Q3 2024 revenues exceeding expectations.
• Operational Profitability: BioCryst has achieved GAAP and non-GAAP operating profits in both Q2 and Q3 2024.
• Global Expansion: The drug is now available in over 20 countries, with significant growth in ex-U.S. markets.
• Strong Patient Demand: High patient retention rates and increasing prescriber confidence are driving commercial momentum.
• Future Developments: The company is advancing its rare disease pipeline, including BCX17725 and avoralstat.
• Financial Milestones: BioCryst is on track to achieve full-year operating profit in 2024 and positive EPS and cash flow by 2026 without additional funding.

FAQs

What is ORLADEYO used for?

ORLADEYO is used to prevent attacks of hereditary angioedema (HAE), a rare genetic disorder.

How has ORLADEYO performed in terms of revenue?

ORLADEYO has shown significant revenue growth, with a 34% y-o-y increase in Q2 2024 and a 35.7% y-o-y increase in Q3 2024.

What are the key drivers of ORLADEYO's commercial success?

The key drivers include strong patient retention, high new patient starts, increased prescriber confidence, and global market expansion.

What is BioCryst's financial outlook for ORLADEYO?

BioCryst expects to achieve full-year operating profit in 2024, approach positive EPS and cash flow in the second half of 2025, and be profitable on an EPS basis with positive cash flow for the full year 2026.

What other products is BioCryst developing in its pipeline?

BioCryst is advancing BCX17725 for Netherton syndrome and avoralstat for diabetic macular edema, among other rare disease products.

Cited Sources

1. BioCryst Pharmaceuticals. BioCryst Reports Second Quarter 2024 Financial Results and Provides Business Update. Stock Titan, August 5, 2024.
2. BioCryst Pharmaceuticals. BioCryst Reports Third Quarter 2024 Financial Results and Provides Business Update. Stock Titan, November 4, 2024.
3. BioCryst Pharmaceuticals. BioCryst Reports Third Quarter 2024 Financial Results and Provides Business Update. BioSpace, November 5, 2024.
4. BioCryst Pharmaceuticals. BioCryst Announces Preliminary Full Year 2023 ORLADEYO Net Revenue of $325 Million, Provides 2024 Guidance and Accelerated Path to Profitability. IR BioCryst, January 5, 2024.
5. BioCryst Pharmaceuticals. BioCryst Announces Preliminary Full Year 2023 ORLADEYO Net Revenue of $325 Million, Provides 2024 Guidance and Accelerated Path to Profitability. BioSpace, January 5, 2024.