INGREZZA Drug Patent Profile

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

Ingrezza is a drug marketed by Neurocrine and is included in two NDAs. There are twenty-two patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-five patent family members in thirty-five countries.

The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ingrezza

A generic version of INGREZZA was approved as valbenazine tosylate by LUPIN LTD on April 5^th, 2024.

Summary for INGREZZA

International Patents:	225
US Patents:	22
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	7
Patent Applications:	163
Drug Prices:	Drug price information for INGREZZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INGREZZA
What excipients (inactive ingredients) are in INGREZZA?	INGREZZA excipients list
DailyMed Link:	INGREZZA at DailyMed

See drug prices for INGREZZA

Recent Clinical Trials for INGREZZA

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

Sponsor	Phase
Neurocrine Biosciences	Phase 4
Stephen Ruedrich	Phase 4
Michael Bloch	Phase 2

See all INGREZZA clinical trials

Pharmacology for INGREZZA

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for INGREZZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INGREZZA	Capsules	valbenazine tosylate	60 mg	209241	1	2022-02-14
INGREZZA	Capsules	valbenazine tosylate	40 mg and 80 mg	209241	4	2021-04-12

US Patents and Regulatory Information for INGREZZA

INGREZZA is protected by thirty-three US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes			Y	Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No			Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes			Y

International Patents for INGREZZA

When does loss-of-exclusivity occur for INGREZZA?

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

Argentina

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Taiwan

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 INGREZZA around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	193767	VALBENAZINE SALTS AND POLYMORPHS THEREOF
Lithuania	3875459
Mexico	2022000559	METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DE VMAT2 A PACIENTES CON INSUFICIENCIA RENAL GRAVE. (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS TO PATIENTS WITH SEVERE RENAL IMPAIRMENT.)
Spain	2857085
Canada	2668689	COMPOSES 3-ISOBUTYL-9, 10-DIMETHOXY-1,3,4,6,7,11B-HEXAHYDRO-2H-PYRIDO[2,1-A] ISOQUINOLIN-2-OL SUBSTITUES ET PROCEDES ASSOCIES (SUBSTITUTED 3-ISOBUTYL-9,10-DIMETHOXY-1,3,4,6,7,11B-HEXAHYDRO-2H-PYRIDO[2,1-A]ISOQUINOLIN-2-OL COMPOUNDS AND METHODS RELATING THERETO)
Croatia	P20240304

Market Dynamics and Financial Trajectory for INGREZZA (Valbenazine)

Introduction

INGREZZA (valbenazine) is a medication developed by Neurocrine Biosciences, Inc., primarily used to treat tardive dyskinesia and chorea associated with Huntington's disease. The drug has shown significant growth and financial success, making it a key player in the neuroscience pharmaceutical market.

Market Demand and Growth

INGREZZA has experienced robust growth driven by strong underlying patient demand. In the second quarter of 2024, INGREZZA net product sales reached $580 million, representing a 32% year-over-year growth compared to the same period in 2023[1].

Similarly, in the third quarter of 2024, INGREZZA net product sales were $613 million, marking a 26% year-over-year growth. This growth is attributed to the increasing adoption of the drug for treating tardive dyskinesia and Huntington's disease chorea, as well as improvements in gross-to-net dynamics[5].

Financial Performance

The financial performance of INGREZZA has been impressive, reflecting the drug's market success.

Quarterly and Annual Sales

• In the fourth quarter of 2023, INGREZZA net product sales were $500 million, with full-year sales reaching $1.84 billion, representing a 29% year-over-year growth[2].
• For 2024, the net product sales guidance for INGREZZA has been raised to $2.30 - $2.32 billion, indicating continued strong growth[5].

Revenue and Earnings

• The revenue growth for Neurocrine Biosciences, driven largely by INGREZZA, stands at 25.72% over the last twelve months as of Q3 2024, with quarterly revenue growth at 24.72%[3].
• Non-GAAP net income and earnings per share for the third quarter of 2024 were $189 million and $1.81, respectively, compared to $156 million and $1.54 in the third quarter of 2023[5].

Key Financial Highlights

Several factors contribute to the financial health of Neurocrine Biosciences and the success of INGREZZA:

Operating Margin and Expenses

• The company has seen an improvement in operating margin, driven by higher INGREZZA net sales. This has contributed to increased Non-GAAP net income and earnings per share[5].
• Research and Development (R&D) expenses have increased to support an expanded and advancing clinical portfolio, including investments in muscarinic compounds, gene therapy programs, and second-generation VMAT2 inhibitors[2].

Cash and Marketable Securities

• As of September 30, 2024, Neurocrine Biosciences had cash, cash equivalents, and marketable securities totaling approximately $1.9 billion, providing a strong financial foundation for continued investment in research and development[5].

Clinical Success and Regulatory Developments

The clinical success of INGREZZA is a significant factor in its market dynamics.

Clinical Outcomes

• Recent studies have shown that INGREZZA can achieve remission in patients with tardive dyskinesia, aligning well with the company's strong financial performance[3].

Regulatory Updates

• The FDA has granted Priority Review for crinecerfont, another Neurocrine Biosciences drug, for the treatment of congenital adrenal hyperplasia in adults and pediatrics. This indicates a deep and focused neuroscience pipeline that supports the company's growth[5].

Expansion and Strategic Initiatives

Neurocrine Biosciences is taking several strategic steps to further enhance the market presence of INGREZZA:

Sales Team Expansion

• The company has announced plans to expand the INGREZZA psychiatry and long-term care sales teams to better serve patients and capitalize on the drug's growing demand[1].

New Formulations

• A new sprinkle formulation of INGREZZA capsules has been launched, making the drug more accessible and convenient for patients with tardive dyskinesia[1].

Share Repurchase Plan

• The board has authorized a $300 million share repurchase plan, reflecting the company's confidence in its financial health and future growth prospects[5].

Industry Impact and Analyst Projections

The success of INGREZZA has significant implications for the broader pharmaceutical industry.

Market Influence

• The robust growth of INGREZZA is influencing analyst projections, with revised earnings upwards for the upcoming period. This is partly due to the positive clinical outcomes and the potential for increased adoption of the drug[3].

Financial Health

• Neurocrine Biosciences' financial health, with a gross profit margin of 68.07% and an operating income margin of 26.85% over the last twelve months, positions the company well for continued investment in research and development[3].

Key Takeaways

• Strong Sales Growth: INGREZZA has shown significant year-over-year growth, driven by strong patient demand and improvements in gross-to-net dynamics.
• Financial Performance: The drug's success has translated into robust financial gains for Neurocrine Biosciences, with increased revenue, net income, and earnings per share.
• Clinical Success: Positive clinical outcomes, including remission in tardive dyskinesia patients, support the drug's market success.
• Strategic Initiatives: Expansion of sales teams, new formulations, and a share repurchase plan indicate the company's confidence in INGREZZA's future growth.

FAQs

What is INGREZZA used for?

INGREZZA (valbenazine) is used to treat tardive dyskinesia and chorea associated with Huntington's disease.

How has INGREZZA performed financially in 2024?

INGREZZA has shown strong financial performance in 2024, with second-quarter net product sales of $580 million and third-quarter sales of $613 million, representing year-over-year growth of 32% and 26%, respectively.

What are the key factors driving INGREZZA's growth?

The growth of INGREZZA is driven by strong underlying patient demand, improvements in gross-to-net dynamics, and the drug's clinical success in treating tardive dyskinesia and Huntington's disease chorea.

What are Neurocrine Biosciences' plans for expanding INGREZZA's market presence?

Neurocrine Biosciences plans to expand the INGREZZA psychiatry and long-term care sales teams and has launched a new sprinkle formulation of INGREZZA capsules.

How does INGREZZA's success impact Neurocrine Biosciences' financial health?

INGREZZA's success has contributed to Neurocrine Biosciences' strong financial health, with a gross profit margin of 68.07% and an operating income margin of 26.85% over the last twelve months, enabling the company to continue investing in research and development.

Sources

1. Neurocrine Biosciences Reports Second Quarter 2024 Financial Results and Raises 2024 INGREZZA Sales Guidance. PR Newswire.
2. Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2023 Financial Results. Neurocrine Biosciences.
3. INGREZZA shows tardive dyskinesia remission in study. Investing.com.
4. Neurocrine Biosciences Reports Third Quarter 2024 Financial Results. Neurocrine Biosciences.
5. Neurocrine Biosciences Reports Third Quarter 2024 Financial Results and Raises 2024 INGREZZA Sales Guidance. PR Newswire.

Last updated: 2024-12-16