INGREZZA SPRINKLE Drug Patent Profile

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

Ingrezza Sprinkle is a drug marketed by Neurocrine and is included in one NDA. There are twenty-two patents protecting this drug.

This drug has two hundred and fourteen patent family members in thirty-four countries.

The generic ingredient in INGREZZA SPRINKLE 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 Sprinkle

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

Summary for INGREZZA SPRINKLE

International Patents:	214
US Patents:	22
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INGREZZA SPRINKLE
DailyMed Link:	INGREZZA SPRINKLE at DailyMed

Pharmacology for INGREZZA SPRINKLE

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

US Patents and Regulatory Information for INGREZZA SPRINKLE

INGREZZA SPRINKLE is protected by thirty-three US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-003	Apr 30, 2024		RX	Yes	Yes	10,906,902		Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No	10,919,892		Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-003	Apr 30, 2024		RX	Yes	Yes	10,857,148
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No	10,874,648
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No	10,065,952		Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No	10,940,141

International Patents for INGREZZA SPRINKLE

See the table below for patents covering INGREZZA SPRINKLE around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	284874	מלחי ולבנאזין ופולימורפים שלהם (Valbenazine salts and polymorphs thereof)
Morocco	43116	DITOSYLATE DE VALBÉNAZINE ET POLYMORPHES ASSOCIÉS
Argentina	112819	FORMULACIÓN Y COMPOSICIONES DE VALBENAZINA DE ALTA DOSIS, MÉTODOS Y EQUIPOS RELACIONADOS
China	108473489
Serbia	65154	SOLI VALBENAZIN DIHIDROHLORIDA I NJIHOVI POLIMORFI (VALBENAZINE DIHYDROCHLORIDE SALTS AND POLYMORPHS THEREOF)
Philippines	12019501734	METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS

INGREZZA SPRINKLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INGREZZA Sprinkle

Introduction to INGREZZA Sprinkle

INGREZZA Sprinkle, developed by Neurocrine Biosciences, is a new formulation of the drug valbenazine, designed to treat tardive dyskinesia and chorea associated with Huntington’s disease. This innovative formulation addresses a significant need for patients who have difficulty swallowing whole capsules.

FDA Approval and Clinical Significance

The FDA approved the sprinkle capsule formulation of INGREZZA in May 2024, based on chemistry, manufacturing, and control information that established its bioequivalence to the original oral capsule version. This approval marks a significant milestone, as it provides a more convenient and accessible treatment option for patients with swallowing difficulties[1][4].

Mechanism of Action

INGREZZA is a selective and reversible inhibitor of the vesicular monoamine transporter 2 (VMAT2), which plays a crucial role in the uptake of monamines from the cell’s cytoplasm into its synaptic vesicle. Although the exact mechanism of action is still unknown, the drug has proven effective in reducing uncontrollable movements associated with tardive dyskinesia and Huntington’s disease chorea[1][4].

Market Demand and Growth

INGREZZA has experienced robust growth driven by strong underlying patient demand. The drug's sales have been increasing steadily, with net product sales reaching $580 million in the second quarter of 2024, representing a 32% 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[2][3].

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, a 25% year-over-year growth.
• For 2024, the net product sales guidance for INGREZZA has been raised to $2.30 - $2.32 billion, indicating continued strong growth[3][5].

Financial Performance

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

Revenue and Earnings

• Neurocrine Biosciences' revenue growth, driven largely by INGREZZA, stands at 25.72% over the last twelve months as of Q3 2024.
• 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[3].

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.
• 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][3].

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[3].

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[3].

New Formulations

The launch of the sprinkle formulation of INGREZZA capsules makes the drug more accessible and convenient for patients with tardive dyskinesia and Huntington’s disease chorea. This new formulation is available in 40mg, 60mg, and 80mg doses and can be sprinkled on soft food for easier administration[1][4].

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[3].

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].

Patient Impact and Clinical Success

INGREZZA has made a significant impact on patients' lives, particularly those with difficulty swallowing.

Swallowing Difficulties

A survey of Huntington’s disease patients with chorea and their caregivers revealed that 62% had difficulty swallowing due to their involuntary movements. For tardive dyskinesia patients with moderate-to-severe involuntary movements, 37% reported problems eating and drinking due to their symptoms. The sprinkle formulation addresses these challenges directly[1].

Clinical Outcomes

INGREZZA has proven effective in reducing uncontrollable movements in patients with tardive dyskinesia and Huntington’s disease chorea. The drug's clinical success supports its market dominance and continued adoption[1][4].

Future Projections

Analysts forecast that INGREZZA sales will continue to grow, with projections suggesting the drug could generate over $3.3 billion in sales by 2030, according to GlobalData analysis[4].

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 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 Sprinkle used for?

INGREZZA Sprinkle is used to treat tardive dyskinesia and chorea associated with Huntington’s disease, particularly for patients who have difficulty swallowing whole capsules.

How does INGREZZA Sprinkle differ from the original formulation?

INGREZZA Sprinkle is designed to be opened and sprinkled on soft food, making it easier for patients with swallowing difficulties to administer the drug.

What are the available doses for INGREZZA Sprinkle?

INGREZZA Sprinkle is available in 40mg, 60mg, and 80mg doses, similar to the original oral capsule version.

How has INGREZZA impacted Neurocrine Biosciences' financials?

INGREZZA has significantly contributed to Neurocrine Biosciences' revenue, with net product sales reaching $1.84 billion in 2023 and projected to be between $2.30 - $2.32 billion in 2024.

What are the future projections for INGREZZA sales?

Analysts project that INGREZZA sales could reach over $3.3 billion by 2030, driven by strong patient demand and positive clinical outcomes.

Sources

1. Biospace: Neurocrine Wins FDA Approval for 'Sprinkle' Formulation of Ingrezza...
2. PR Newswire: Neurocrine Biosciences Reports Second Quarter 2024 Financial Results...
3. DrugPatentWatch: INGREZZA Drug Patent Profile
4. Pharmaceutical Technology: Neurocrine bags FDA approval for new 'sprinkle' Ingrezza formulation
5. Neurocrine Biosciences: Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2023...