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NULIBRY Drug Patent Profile

When do Nulibry patents expire, and when can generic versions of Nulibry launch?

Nulibry is a drug marketed by Sentynl Theraps Inc and is included in one NDA. There is one patent protecting this drug.

This drug has ten patent family members in ten countries.

The generic ingredient in NULIBRY is fosdenopterin hydrobromide. One supplier is listed for this compound. Additional details are available on the fosdenopterin hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Nulibry

Nulibry will be eligible for patent challenges on February 26, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 26, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NULIBRY

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for NULIBRY
What excipients (inactive ingredients) are in NULIBRY?	NULIBRY excipients list
DailyMed Link:	NULIBRY at DailyMed

See drug prices for NULIBRY

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

Constraining patent/regulatory exclusivity:

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

NDA:

214018

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 NULIBRY

Drug Class

Cyclic Pyranopterin Monophosphate

US Patents and Regulatory Information for NULIBRY

NULIBRY is protected by one US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	7,504,095		Y
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

International Patents for NULIBRY

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1664317
Germany	102004004642	Produktion, Gewinnung und therapeutischer Einsatz des Molybdopterin-Derivats Precursor Z zur Therapie der Stoffwechselerkrankung humaner Molybdäncofaktor-Defizienz und anderer assoziierter Krankheiten
Spain	2406733
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
Denmark	1664317

NULIBRY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NULIBRY

Introduction to NULIBRY

NULIBRY (fosdenopterin) is a groundbreaking treatment for Molybdenum Cofactor Deficiency (MoCD) Type A, an ultra-rare and life-threatening genetic disorder. Approved by the U.S. FDA in February 2021, NULIBRY has since received approvals in Israel and Great Britain, marking significant milestones in its market trajectory.

Market Approval and Expansion

U.S. Approval

NULIBRY was the first therapy approved by the U.S. FDA for the treatment of MoCD Type A, a condition that affects fewer than 150 patients globally and has a median overall survival age of about four years[1][3][4].

International Approvals

In addition to U.S. approval, NULIBRY has been approved in Israel and more recently in Great Britain. The Israeli Ministry of Health's approval and the MHRA authorization in Great Britain have expanded the drug's reach, providing critical treatment options for patients in these regions[1][3][4].

European Union

The Committee for Medicinal Products for Human Use (CHMP) recommended approval of NULIBRY in the European Union in July 2022, paving the way for potential EU-wide authorization[1].

Ownership and Commercialization

Sentynl Therapeutics

In March 2022, Sentynl Therapeutics acquired the global rights to NULIBRY from BridgeBio Pharma. Sentynl is now responsible for the ongoing development, manufacturing, and commercialization of fosdenopterin globally[1][3][4].

Medison Pharma

Medison Pharma holds the commercialization rights to NULIBRY in Israel, ensuring the drug's availability in this market[1].

Clinical Efficacy and Safety

The approval of NULIBRY is supported by robust clinical data. Studies have shown that NULIBRY-treated patients have a 5.5 times lower risk of death compared to untreated patients. Additionally, the survival probability at 3 years of age is significantly higher for NULIBRY-treated patients, at 85.5%, compared to 55.1% for untreated control patients[3][4].

Financial Implications

Revenue and Expenses

BridgeBio Pharma, the original developer of NULIBRY, has reported significant financial activities related to the drug. While the company's overall revenue and expenses are influenced by multiple factors, the approval and commercialization of NULIBRY contribute to their financial trajectory. For instance, BridgeBio ended 2022 with $466.2 million in cash, cash equivalents, and marketable securities, down from $787.7 million in 2021, largely due to operating expenses[2].

Operating Costs

The development and commercialization of NULIBRY are part of BridgeBio's substantial research, development, and other operating costs. In 2022, these costs totaled $402.9 million, with selling, general, and administrative expenses adding another $143.2 million[2].

Partnerships and Agreements

BridgeBio has also benefited from partnerships, such as the Navire-BMS License Agreement, which provided a $90 million upfront payment. These agreements help offset the net cash used in operating activities and support the ongoing development and commercialization of NULIBRY[2][5].

Market Impact

Addressing Unmet Needs

NULIBRY's approval addresses a significant unmet need for patients with MoCD Type A, a condition previously without a treatment option. This approval opens up new market opportunities and enhances the quality of life for these patients and their caregivers[1][3][4].

Competitive Landscape

As the first and only approved therapy for MoCD Type A, NULIBRY holds a unique position in the market. This exclusivity, combined with its proven efficacy and safety, positions NULIBRY as a leader in the treatment of this ultra-rare disease.

Future Outlook

Global Expansion

With approvals in multiple regions and a positive CHMP opinion, NULIBRY is poised for further global expansion. This could include additional regulatory approvals and market entries, further increasing its market reach and impact.

Continued Development

Sentynl Therapeutics' commitment to ongoing development and commercialization ensures that NULIBRY will continue to be a focal point in the treatment of MoCD Type A. This ongoing effort may also lead to new indications or improvements in the treatment regimen.

Key Takeaways

• Unique Market Position: NULIBRY is the first and only approved therapy for MoCD Type A globally.
• Clinical Efficacy: NULIBRY significantly reduces the risk of mortality and improves survival rates for patients with MoCD Type A.
• Global Expansion: Approvals in the U.S., Israel, and Great Britain, with potential EU-wide authorization.
• Financial Impact: Significant operating costs and revenues associated with NULIBRY's development and commercialization.
• Partnerships: Strategic agreements support the financial trajectory of NULIBRY.

FAQs

What is NULIBRY used for?

NULIBRY (fosdenopterin) is used to treat Molybdenum Cofactor Deficiency (MoCD) Type A, an ultra-rare and life-threatening genetic disorder.

Who approved NULIBRY?

NULIBRY has been approved by the U.S. FDA, the Israeli Ministry of Health, and the MHRA in Great Britain. It also received a positive opinion from the CHMP for potential EU approval.

How effective is NULIBRY?

Studies have shown that NULIBRY-treated patients have a 5.5 times lower risk of death and an 85.5% survival probability at 3 years of age, compared to 55.1% for untreated patients.

Who owns the global rights to NULIBRY?

Sentynl Therapeutics acquired the global rights to NULIBRY from BridgeBio Pharma in March 2022.

What are the common symptoms of MoCD Type A?

Common symptoms include seizures, feeding difficulties, and encephalopathy, leading to progressive brain damage and severe psychomotor impairment.

Cited Sources

1. BridgeBio Pharma, Sentynl Therapeutics and Medison Pharma Announce Approval in Israel for NULIBRY (Fosdenopterin) for the Treatment of MoCD Type A. BioSpace.
2. BridgeBio Pharma Reports Fourth Quarter and Full Year 2022 Financial Results. BridgeBio Pharma.
3. Sentynl Therapeutics Receives MHRA Authorization of NULIBRY (Fosdenopterin) for Treatment of MoCD Type A in Great Britain. PR Newswire.
4. Sentynl Therapeutics Receives MHRA Authorization of NULIBRY (Fosdenopterin) for Treatment of MoCD Type A in Great Britain. PR Newswire.
5. BridgeBio Pharma Inc. Reports Third Quarter 2022 Financial Results and Business Update. BridgeBio.