KUVAN Drug Patent Profile

Which patents cover Kuvan, and what generic alternatives are available?

Kuvan is a drug marketed by Biomarin Pharm and is included in two NDAs. There are ten patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and seventeen patent family members in twenty-six countries.

The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kuvan

A generic version of KUVAN was approved as sapropterin dihydrochloride by ENDO OPERATIONS on May 10^th, 2019.

Summary for KUVAN

International Patents:	117
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	182
Drug Prices:	Drug price information for KUVAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KUVAN
What excipients (inactive ingredients) are in KUVAN?	KUVAN excipients list
DailyMed Link:	KUVAN at DailyMed

See drug prices for KUVAN

Pharmacology for KUVAN

Drug Class	Phenylalanine Hydroxylase Activator
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors Phenylalanine Hydroxylase Activators

Paragraph IV (Patent) Challenges for KUVAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	500 mg per packet	205065	1	2017-02-23
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	100 mg per packet	205065	1	2015-11-09
KUVAN	Tablets	sapropterin dihydrochloride	100 mg	022181	1	2014-06-05

US Patents and Regulatory Information for KUVAN

KUVAN is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes	8,067,416*PED
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes	8,067,416*PED
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015	AB	RX	Yes	No	7,612,073*PED

Expired US Patents for KUVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	7,727,987*PED
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	RE43797*PED
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	8,067,416*PED

International Patents for KUVAN

See the table below for patents covering KUVAN around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101721198
Portugal	1708690
European Patent Office	1845952	FORMULE STABLE DE COMPRIMES DE TETRAHYDROBIOPTERINE (STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN)

Market Dynamics and Financial Trajectory for KUVAN (Sapropterin Hydrochloride)

Introduction to KUVAN (Sapropterin Hydrochloride)

KUVAN (Sapropterin Hydrochloride) is a pharmaceutical drug developed by BioMarin Pharmaceutical Inc. for the treatment of Phenylketonuria (PKU), a genetic disorder characterized by the inability to break down the amino acid phenylalanine. Here, we delve into the market dynamics and financial trajectory of KUVAN.

Mechanism of Action and Clinical Use

KUVAN works by increasing the activity of the enzyme phenylalanine hydroxylase, which is deficient in individuals with PKU. This helps in reducing blood phenylalanine levels, thereby mitigating the severe effects of the disorder on the brain, such as intellectual disability and psychiatric symptoms[4].

Market Assessment

Current Market Scenario

The market for KUVAN is primarily driven by its approval and use in the 7 Major Markets (7MM), including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. The drug has been a significant player in the PKU treatment market, but it faces increasing competition from emerging therapies.

Competitive Landscape

The PKU treatment market is witnessing the emergence of new therapies, such as Palynziq (pegvaliase), which has been approved by regulatory bodies. Palynziq is expected to achieve peak annual sales of over $500 million by 2029, posing a significant competitive threat to KUVAN[3].

Additionally, generic versions of KUVAN are expected to enter the market, further intensifying competition. BioMarin has reached settlements with generics manufacturers like Par Pharmaceuticals and Dr. Reddy's Laboratories, but these generic versions can still be marketed starting from 2020 or 2021[3].

Regulatory Milestones

KUVAN has undergone extensive clinical trials and has received regulatory approvals in various regions. The drug's regulatory milestones and ongoing developmental activities are closely monitored, as they impact its market position and future sales projections[1][4].

Financial Performance

Revenue Trends

KUVAN's net product revenues have shown a declining trend in recent years. For instance, in the third quarter of 2022, KUVAN's net product revenues were $57.0 million, a 16% decrease from the same period in 2021. Similarly, for the full year 2021, KUVAN's net product revenues were $285.8 million, a 38% decline from 2020[2][5].

Impact on BioMarin's Financials

Despite the decline in KUVAN revenues, BioMarin's overall financial performance has been supported by the growth of other products. In the third quarter of 2022, BioMarin's total revenues increased by 24% year-over-year, driven by the success of other drugs like VOXZOGO and BRINEURA. However, the decline in KUVAN revenues has been a significant factor in the company's financial dynamics[2].

Cost and Expense Structure

BioMarin's operating expenses, including research and development, selling, general and administrative costs, and intangible asset amortization, have been significant. The company has also incurred costs related to the commercial launch of new products and organizational redesign. These expenses have impacted the net income and profitability of the company[2][5].

Market Forecast

Sales Projections

The market size for KUVAN in the 7MM is forecasted to evolve over the period from 2019 to 2032. Despite the competitive pressures, KUVAN is expected to maintain a significant market presence, although its dominance may be challenged by emerging therapies. Detailed sales data and market size projections for KUVAN in various regions, including the United States, EU5, and Japan, are available, providing insights into the drug's future market trajectory[1][4].

Competitive Impact

The launch of late-stage emerging therapies is expected to significantly impact the market for KUVAN. Companies are developing novel approaches to treat PKU, which will assess challenges and seek opportunities that could influence KUVAN's market position. The competitive landscape, including both marketed therapies and late-stage emerging therapies, will be crucial in determining KUVAN's future market share[1].

Strategic Implications

Leveraging Commercial Experience

BioMarin's strategy to leverage the commercial experience gained from KUVAN to support the launch of new products, such as Palynziq, is critical. This approach helps in expanding the company's footprint in the PKU market and mitigating the impact of declining KUVAN revenues[3].

Diversification and Pipeline Development

BioMarin's focus on diversifying its product portfolio and developing its pipeline is essential for long-term growth. The company's investments in new product launches, such as VOXZOGO and ROCTAVIAN, and its ongoing research and development activities are key to maintaining a strong market position[2].

Key Takeaways

• Market Competition: KUVAN faces increasing competition from emerging therapies and generic versions.
• Financial Performance: KUVAN's revenues have declined, but BioMarin's overall financials are supported by other products.
• Regulatory Milestones: Ongoing regulatory activities and approvals are crucial for KUVAN's market position.
• Market Forecast: Detailed sales projections indicate a evolving market size for KUVAN from 2019 to 2032.
• Strategic Implications: Leveraging commercial experience and diversifying the product portfolio are key strategies for BioMarin.

FAQs

What is KUVAN (Sapropterin Hydrochloride) used for?

KUVAN (Sapropterin Hydrochloride) is used to treat Phenylketonuria (PKU), a genetic disorder characterized by the inability to break down the amino acid phenylalanine.

How does KUVAN work?

KUVAN works by increasing the activity of the enzyme phenylalanine hydroxylase, which helps in reducing blood phenylalanine levels.

What are the competitive threats to KUVAN?

KUVAN faces competition from emerging therapies like Palynziq (pegvaliase) and generic versions from manufacturers like Par Pharmaceuticals and Dr. Reddy's Laboratories.

How has KUVAN's revenue trend been in recent years?

KUVAN's net product revenues have shown a declining trend, with a 16% decrease in the third quarter of 2022 and a 38% decline for the full year 2021 compared to 2020.

What is BioMarin's strategy to mitigate the decline in KUVAN revenues?

BioMarin is leveraging the commercial experience gained from KUVAN to support the launch of new products and diversifying its product portfolio through investments in new product launches and research and development activities.

Sources

1. Research and Markets: KUVAN (Sapropterin Hydrochloride), Drug Insight and Market Forecast - 2032.
2. BioPharma Dive: BioMarin Announces Third Quarter 2022 Year-over-Year Total Revenue Growth of 24 Percent.
3. BioPharma Dive: BioMarin cleared to bring new PKU drug to market.
4. PR Newswire: KUVAN (Sapropterin Hydrochloride): Indicated to Reduce Blood Phe Levels in Patients with HPA due to Tetrahydrobiopterin (BH4)-Responsive PKU.
5. BioMarin Investor Relations: BioMarin Announces Fourth Quarter and Full Year 2021 Financial Results and Corporate Updates.

Last updated: 2024-12-16