FOSDENOPTERIN HYDROBROMIDE - Generic Drug Details

What are the generic sources for fosdenopterin hydrobromide and what is the scope of patent protection?

Fosdenopterin hydrobromide is the generic ingredient in one branded drug marketed by Sentynl Theraps Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Fosdenopterin hydrobromide has ten patent family members in ten countries.

One supplier is listed for this compound.

Summary for FOSDENOPTERIN HYDROBROMIDE

International Patents:	10
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in FOSDENOPTERIN HYDROBROMIDE?	FOSDENOPTERIN HYDROBROMIDE excipients list
DailyMed Link:	FOSDENOPTERIN HYDROBROMIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A

Dosage:

POWDER;INTRAVENOUS

^*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.

Pharmacology for FOSDENOPTERIN HYDROBROMIDE

Drug Class

Cyclic Pyranopterin Monophosphate

Anatomical Therapeutic Chemical (ATC) Classes for FOSDENOPTERIN HYDROBROMIDE

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for FOSDENOPTERIN HYDROBROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sentynl Theraps Inc	NULIBRY	fosdenopterin hydrobromide	POWDER;INTRAVENOUS	214018-001	Feb 26, 2021		RX	Yes	Yes
Sentynl Theraps Inc	NULIBRY	fosdenopterin hydrobromide	POWDER;INTRAVENOUS	214018-001	Feb 26, 2021		RX	Yes	Yes
Sentynl Theraps Inc	NULIBRY	fosdenopterin hydrobromide	POWDER;INTRAVENOUS	214018-001	Feb 26, 2021		RX	Yes	Yes	7,504,095		Y
Sentynl Theraps Inc	NULIBRY	fosdenopterin hydrobromide	POWDER;INTRAVENOUS	214018-001	Feb 26, 2021		RX	Yes	Yes

International Patents for FOSDENOPTERIN HYDROBROMIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1664317	Utilisation du précurseur Z pour produire un agent servant à traiter la déficience humaine en cofacteur molybdène (Use of precursor Z for the production of a means for therapy of human molybdenum cofactor deficiency)
Cyprus	1113960
Slovenia	1664317
Canada	2554461	PROCEDE DE PRODUCTION DU PRECURSEUR Z ET SON UTILISATION POUR PRODUIRE UN AGENT SERVANT A TRAITER LA DEFICIENCE HUMAINE EN COFACTEUR MOLYBDENE (METHOD FOR OBTAINING PRECURSOR Z AND USE THEREOF FOR THE PRODUCTION OF A MEANS FOR THERAPY OF HUMAN MOLYBDENUM COFACTOR DEFICIENCY)
Poland	1664317
Portugal	1664317

FOSDENOPTERIN HYDROBROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fosdenopterin Hydrobromide (Nulibry)

Introduction

Fosdenopterin hydrobromide, marketed under the brand name Nulibry, is a groundbreaking medication approved for the treatment of molybdenum cofactor deficiency type A (MoCD-A), a rare and severe genetic disorder. This article delves into the market dynamics and financial trajectory of this first-in-class medication.

Medical Significance and Approval

Fosdenopterin is the first FDA-approved treatment for MoCD-A, a condition characterized by the inability to produce cyclic pyranopterin monophosphate (cPMP), a crucial precursor for several essential enzymes. The drug was approved by the FDA in February 2021 and later in the European Union in September 2022[3][5].

Mechanism of Action and Clinical Impact

Fosdenopterin works by replacing the missing cPMP in the body, thereby enabling the proper functioning of enzymes such as sulfite oxidase, xanthine dehydrogenase/oxidase, and aldehyde oxidase. Clinical trials demonstrated a significant improvement in survival rates among patients treated with fosdenopterin, with an 84% survival rate at three years compared to 55% for untreated participants[3].

Market Approval and Designations

The FDA granted fosdenopterin priority review, breakthrough therapy, and orphan drug designations, along with a rare pediatric disease priority review voucher. These designations underscore the drug's innovative nature and its potential to address a critical unmet medical need[3][5].

Regulatory Landscape

In addition to FDA approval, fosdenopterin received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2022, leading to its approval in the European Union under exceptional circumstances[3].

Market Coverage and Accessibility

Given its orphan drug status, fosdenopterin is likely to be covered by various healthcare systems and insurance plans, especially in regions where it has been approved. This coverage is crucial for ensuring accessibility to patients who require this life-saving treatment.

Competitive Analysis

As the first and only approved treatment for MoCD-A, fosdenopterin currently holds a monopoly in this niche market. This unique position allows it to capture the entire market share for this specific indication, making it a significant player in the rare genetic disorder treatment segment[1][3].

Financial Trajectory

Approval and Launch Impact

The approval and subsequent launch of fosdenopterin in 2021 marked a significant milestone for Origin Biosciences Inc., the company behind the drug. The launch was accompanied by substantial investment in marketing and educational campaigns to raise awareness among healthcare providers and patients about this new treatment option.

Revenue Projections

Given the rare nature of MoCD-A and the lack of alternative treatments, fosdenopterin is expected to generate substantial revenue. The drug's high price point, typical for orphan drugs, will contribute to its financial performance. While exact revenue figures are not publicly disclosed, the drug's unique market position and critical medical need suggest a strong financial outlook.

Cost and Pricing

Orphan drugs like fosdenopterin often come with a high price tag due to the limited patient population and the significant investment required for research and development. The cost of fosdenopterin will likely be substantial, reflecting its innovative nature and the value it brings to patients with MoCD-A.

Market Dynamics

Patient Population

The patient population for MoCD-A is extremely small, which can impact the overall market size. However, the critical need for this treatment and the lack of alternatives ensure a consistent demand for fosdenopterin.

Healthcare System Impact

The integration of fosdenopterin into healthcare systems will involve educational programs for healthcare providers, patient advocacy efforts, and reimbursement negotiations. These activities will be crucial in ensuring that patients have access to this life-saving treatment.

Future Developments

As research continues, there may be potential for fosdenopterin to be explored for other indications or for combination therapies. However, its current focus remains on treating MoCD-A.

Key Takeaways

• First-in-Class Treatment: Fosdenopterin is the first FDA-approved treatment for MoCD-A.
• Significant Clinical Impact: It significantly improves survival rates in patients with MoCD-A.
• Regulatory Support: Received priority review, breakthrough therapy, and orphan drug designations.
• Market Monopoly: Currently the only approved treatment for MoCD-A.
• Financial Outlook: Expected to generate substantial revenue due to its high price point and critical medical need.
• Accessibility: Covered by various healthcare systems and insurance plans.

FAQs

What is fosdenopterin hydrobromide used for?

Fosdenopterin hydrobromide, marketed as Nulibry, is used to reduce the risk of death in patients with molybdenum cofactor deficiency type A (MoCD-A), a rare genetic disorder.

When was fosdenopterin approved by the FDA?

Fosdenopterin was approved by the FDA on February 26, 2021[2][3].

What are the common side effects of fosdenopterin?

Common side effects include complications related to the intravenous line, fever, respiratory infections, vomiting, gastroenteritis, and diarrhea[3].

How does fosdenopterin work?

Fosdenopterin works by replacing the missing cyclic pyranopterin monophosphate (cPMP) in the body, enabling the proper functioning of essential enzymes[3].

Is fosdenopterin covered by insurance?

Given its orphan drug status, fosdenopterin is likely to be covered by various healthcare systems and insurance plans, ensuring accessibility to patients who require this treatment.

Sources

1. GlobalData: BridgeBio Pharma Marketed Drugs - GlobalData
2. New Drug Approvals: Fosdenopterin hydrobromide - New Drug Approvals
3. Wikipedia: Fosdenopterin - Wikipedia
4. Oregon Drug Use Review: Oregon Drug Use Review / Pharmacy & Therapeutics Committee ...
5. Touch Neurology: Fosdenopterin: a First-in-class Synthetic Cyclic Pyranopterin ...