NITYR Drug Patent Profile

When do Nityr patents expire, and what generic alternatives are available?

Nityr is a drug marketed by Cycle and is included in one NDA. There is one patent protecting this drug.

This drug has fifteen patent family members in fifteen countries.

The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nityr

A generic version of NITYR was approved as nitisinone by NOVITIUM PHARMA on August 26^th, 2019.

Summary for NITYR

International Patents:	15
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	541
Drug Prices:	Drug price information for NITYR
What excipients (inactive ingredients) are in NITYR?	NITYR excipients list
DailyMed Link:	NITYR at DailyMed

See drug prices for NITYR

Pharmacology for NITYR

Drug Class	4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 2E1 Inducers Hydroxyphenylpyruvate Dioxygenase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

US Patents and Regulatory Information for NITYR

NITYR is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle	NITYR	nitisinone	TABLET;ORAL	209449-001	Jul 26, 2017		RX	Yes	No	10,328,029		Y
Cycle	NITYR	nitisinone	TABLET;ORAL	209449-002	Jul 26, 2017		RX	Yes	No	10,328,029		Y
Cycle	NITYR	nitisinone	TABLET;ORAL	209449-003	Jul 26, 2017		RX	Yes	Yes	10,328,029		Y

EU/EMA Drug Approvals for NITYR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
MendeliKABS Europe Ltd	Nitisinone MDK (previously Nitisinone MendeliKABS)	nitisinone	EMEA/H/C/004281 Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.	Withdrawn	yes	no	no	2017-08-24
Cycle Pharmaceuticals (Europe) Ltd	Nityr	nitisinone	EMEA/H/C/004582 Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	Authorised	yes	no	no	2018-07-26
Swedish Orphan Biovitrum International AB	Orfadin	nitisinone	EMEA/H/C/000555 Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).	Authorised	no	no	no	2005-02-21

International Patents for NITYR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3089740	COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Slovenia	3089740
San Marino	T202000391
Serbia	60551	FARMACEUTSKA KOMPOZICIJA (PHARMACEUTICAL COMPOSITION)
Hungary	E050881
Lithuania	3089740

Supplementary Protection Certificates for NITYR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0591275	05C0024	France		PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
0591275	C300198	Netherlands		PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221

Market Dynamics and Financial Trajectory for NITYR (Nitisinone)

Introduction to Nitisinone

Nitisinone, marketed as NITYR, is a medication primarily used to treat hereditary tyrosinemia type 1 (HT-1), a rare and severe genetic disorder. The drug has gained significant traction due to its efficacy in managing this condition and the increasing awareness of rare diseases.

Global Market Size and Growth

The global Nitisinone market is projected to experience substantial growth. As of 2024, the market size is estimated to be around USD 101.5 million and is expected to expand to USD 205.47 million by 2031, with a Compound Annual Growth Rate (CAGR) of 10.60% from 2024 to 2031[2].

Key Drivers of Market Growth

Several factors are driving the growth of the Nitisinone market:

Rising Prevalence of Rare Genetic Disorders

The increasing awareness and early diagnosis of rare genetic disorders, such as HT-1, are significant drivers. This rise in diagnosis rates is partly due to advancements in genetic testing and increased awareness campaigns[2].

Expanding Healthcare Infrastructure

Improving healthcare infrastructure, especially in emerging markets like the Asia Pacific region, is another key driver. Countries such as China, India, and Japan are experiencing rapid growth in their healthcare sectors, which includes better access to diagnostic and treatment services for patients with HT-1[2].

Government Incentives

Supportive government incentives for orphan drugs also play a crucial role. These incentives can include tax credits, grants, and expedited approval processes, which encourage pharmaceutical companies to invest in the development and marketing of drugs like Nitisinone[2].

Regional Market Dynamics

North America

North America currently dominates the Nitisinone market due to its high prevalence of HT-1 and advanced healthcare infrastructure. However, the region's growth rate is expected to be lower compared to other regions[2].

Asia Pacific

The Asia Pacific region is growing at the fastest CAGR, driven by improving healthcare infrastructure, increased awareness of rare diseases, and expanding access to diagnostic and treatment services. This region is expected to be a significant contributor to the global market growth[2].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also show potential for growth, although at a slower pace compared to North America and the Asia Pacific. These regions are expected to grow at CAGRs of 10.0% and 10.3%, respectively, from 2024 to 2031[2].

Financial Performance of Key Players

Sobi and Cycle Pharmaceuticals

Sobi and Cycle Pharmaceuticals are major players in the Nitisinone market. These companies have made significant investments in research and development and have expanded the availability of Nitisinone treatments. Cycle Pharmaceuticals, for instance, has introduced NITYR, an FDA-approved tablet for treating HT-1, which has been well-received due to its convenience and efficacy[2][4].

Eton Pharmaceuticals

Eton Pharmaceuticals, another company involved in the rare disease treatment market, has reported significant financial growth. In Q4 2023, they achieved a 109% year-over-year increase in product sales and royalty revenue, reaching $7.3 million. This growth is partly attributed to the success of their products like ALKINDI SPRINKLE and Carglumic Acid, which are used in treating rare conditions[2].

Challenges and Restraints

High Cost of Nitisinone

One of the significant challenges facing the Nitisinone market is the high cost of the drug. This can limit accessibility, especially in regions with less robust healthcare systems. The cost can be a barrier for many patients, making it essential for companies to explore pricing strategies and patient assistance programs[2].

Regulatory Challenges

Regulatory hurdles can also restrain market expansion. The approval process for orphan drugs can be complex and time-consuming, affecting the timely availability of Nitisinone in various markets. These regulatory challenges require careful navigation by pharmaceutical companies to ensure compliance and timely market entry[2].

Recent Developments and Innovations

Generic Nitisinone Capsules

Analog Pharma and Dipharma have recently received FDA approval for their 20 mg generic nitisinone capsules, which are stable at room temperature for 3 years. This development is expected to improve patient access and compliance by providing a more affordable and stable formulation[2].

Pipeline Developments

Companies like Eton Pharmaceuticals are making significant strides in their pipelines. For example, Eton's ET-400, a proprietary formulation of oral hydrocortisone, has passed its pivotal bioequivalence study and is on track for NDA submission in Q2 2024. These pipeline advancements indicate a promising future for the treatment of rare diseases[2].

Market Trends

Personalized Medicine

There is a growing emphasis on personalized medicine, which includes tailored treatments for rare genetic disorders. This trend is expected to drive innovation and demand for Nitisinone as healthcare providers seek more precise and effective treatments for patients with HT-1[2].

Expanding Healthcare Infrastructure

Improving healthcare infrastructure in emerging markets is another trend that supports the growth of the Nitisinone market. This expansion increases access to diagnostic and treatment services for patients with HT-1, thereby increasing the potential market size[2].

Increased Investment in R&D

Increased investment in research and development for rare diseases is a significant trend. This investment is crucial for developing new treatments and improving existing ones, such as Nitisinone. Pharmaceutical companies are strategically aligning their R&D investments to address unmet medical needs, shaping the future trajectory of healthcare innovation[2].

Key Takeaways

• Market Growth: The global Nitisinone market is expected to grow significantly, reaching USD 205.47 million by 2031.
• Key Drivers: The rising prevalence of HT-1, increased awareness and early diagnosis, and supportive government incentives are key drivers.
• Regional Dynamics: North America dominates the market, but the Asia Pacific region is growing at the fastest CAGR.
• Challenges: High costs and regulatory challenges are significant restraints.
• Recent Developments: The approval of generic nitisinone capsules and pipeline advancements are improving market dynamics.

FAQs

What is the current global market size for Nitisinone? The global Nitisinone market size is estimated to be USD 101.5 million in 2024[2].

What is the projected CAGR for the Nitisinone market from 2024 to 2031? The Nitisinone market is expected to grow at a CAGR of 10.60% from 2024 to 2031[2].

Which region dominates the Nitisinone market? North America currently dominates the Nitisinone market due to its high prevalence of HT-1 and advanced healthcare infrastructure[2].

What are the main challenges facing the Nitisinone market? The main challenges include the high cost of the drug and regulatory hurdles[2].

What recent developments have improved the Nitisinone market? Recent developments include the FDA approval of generic nitisinone capsules and advancements in pipeline products like Eton's ET-400[2].

Highlight: Regulatory Approvals and Patient Access

"The inclusion of the once daily dosing option in the NITYR Prescribing Information provides NITYR’s patients and their prescribers with greater flexibility in dosing and titration. This new option may be more convenient to patients and their caregivers in their daily management," said Zac Bohlen, Head of Operations in the US, Cycle[4].

This quote highlights the importance of regulatory approvals in enhancing patient access and convenience, a critical factor in the market dynamics of Nitisinone.

Sources

1. Global Nitisinone Market Research Report 2024 - Valuates Reports[1]
2. Generic NITISINONE INN entry, pharmaceutical patent expiration - Drug Patent Watch[2]
3. Investment Trends in Pharmaceutical Research - DrugBank Blog[3]
4. US FDA Grants Once Daily Dosing Option for NITYR (nitisinone) Tablets for HT-1 Patients - BioSpace[4]
5. NITYR® (nitisinone) Tablets - Cycle Vita[5]

Last updated: 2024-12-18