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JESDUVROQ Drug Patent Profile

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

Jesduvroq is a drug marketed by Glaxosmithkline and is included in one NDA. There are six patents protecting this drug.

This drug has forty-two patent family members in thirty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Jesduvroq

Jesduvroq will be eligible for patent challenges on February 1, 2027. 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 1, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JESDUVROQ

International Patents:	42
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Patent Applications:	22
Drug Prices:	Drug price information for JESDUVROQ
What excipients (inactive ingredients) are in JESDUVROQ?	JESDUVROQ excipients list
DailyMed Link:	JESDUVROQ at DailyMed

See drug prices for JESDUVROQ

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216951

Dosage:

TABLET;ORAL

^*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.

Recent Clinical Trials for JESDUVROQ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GlaxoSmithKline	Phase 4
USRC Kidney Research	Phase 4

See all JESDUVROQ clinical trials

US Patents and Regulatory Information for JESDUVROQ

JESDUVROQ is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-005	Feb 1, 2023		DISCN	Yes	No	11,649,217		Y
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-004	Feb 1, 2023		DISCN	Yes	No
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-005	Feb 1, 2023		DISCN	Yes	No	11,643,397			Y
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-005	Feb 1, 2023		DISCN	Yes	No	11,117,871		Y	Y
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-001	Feb 1, 2023		DISCN	Yes	No	11,117,871		Y	Y

International Patents for JESDUVROQ

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

Country	Patent Number	Title	Estimated Expiration
Ukraine	100225	ІНГІБІТОРИ ПРОЛІЛГІДРОКСИЛАЗ;ИНГИБИТОРЫ ПРОЛИЛГИДРОКСИЛАЗ (PROLYL HYDROXYLASE INHIBITORS)
Eurasian Patent Organization	018220	ИНГИБИТОРЫ ПРОЛИЛГИДРОКСИЛАЗ (PROLYL HYDROXYLASE INHIBITORS)
Costa Rica	10534	INHIBIDORES DE PROLIL HIDROXILASA
European Patent Office	3682884	FORME CRISTALLINE DE GSK1278863 ET SON PROCÉDÉ DE PRÉPARATION ET SON UTILISATION PHARMACEUTIQUE (CRYSTAL FORM OF GSK1278863 AND PREPARATION METHOD AND PHARMACEUTICAL USE THEREOF)
Argentina	061570	COMPUESTO DE GLICINA SUSTITUIDO EN EL N HETEROAROMATICO COMPOSICION FARMACEUTICA QUE LO COMPRENDE, SU USO PARA PREPARAR UN MEDICAMENTO, PROCEDIMIENTOS PARA PREPARAR DICHA COMPOSICION FARMACEUTICA Y PARA PREPARAR EL COMPUESTO

JESDUVROQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Jesduvroq

Introduction to Jesduvroq

Jesduvroq, also known as daprodustat, is a significant addition to the treatment landscape for anemia associated with chronic kidney disease (CKD). It is the first new medicine for anemia treatment in over 30 years and the only hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to receive FDA approval[4].

FDA Approval and Label Limitations

The FDA approved Jesduvroq for use in adult dialysis patients with anemia caused by CKD, but the approval comes with several limitations. The drug is only approved for patients who have been on dialysis for at least four months, which restricts its potential patient pool. Additionally, the approval includes a black box warning for increased risks of death, heart attack, stroke, and thrombosis of vascular access[1][4].

Physician Response and Prescribing Trends

A survey by Spherix Global Insights revealed mixed reactions from nephrologists regarding the FDA approval. While some are positive about having another treatment option, many are cautious due to the drug's limited label and the associated black box warning. The majority of surveyed nephrologists supported the black box warning but indicated that these limitations will lead to a slower and more cautious approach to prescribing Jesduvroq[1].

Patient Pool and Market Uptake

The potential patient pool for Jesduvroq is smaller than anticipated due to several factors. Many patients are already on erythropoiesis-stimulating agents (ESAs) for anemia before starting dialysis, making a switch to Jesduvroq after four months on dialysis complicated and potentially unnecessary. Additionally, risk factors such as cardiovascular disease, hypertension, and cancer further limit the pool of eligible patients[1].

Financial Projections and Market Impact

Despite the limitations, Jesduvroq is expected to generate significant revenue, although at a slower pace than initially anticipated. Barclays estimates that Jesduvroq sales could top out at £364 million ($450 million)[4].

Competitive Landscape

Jesduvroq enters a market where other HIF-PHIs have been approved for broader use, including non-dialysis patients. This difference in approval scope may impact Jesduvroq's market share and adoption rates. The anemia treatment landscape is expected to evolve with the potential launch of other HIF-PHI assets in the U.S. and other global regions[1][4].

GSK's Overall Performance and Strategic Outlook

GSK's financial performance in 2023 was strong, driven by significant growth in Vaccines and Specialty Medicines. The company's pipeline is robust, with 71 vaccines and medicines in clinical development and multiple new product launches planned from 2025 onwards. While Jesduvroq's approval is a milestone, it is part of a broader strategy that includes investments in innovative assets and technologies to drive future growth[2][3][5].

Impact on GSK's Revenue and Growth

The approval of Jesduvroq, although limited, contributes to GSK's diversified revenue stream. The company's sales, excluding COVID-19 solutions, grew at double-digit levels in 2023, with a strong performance from new products launched since 2017. GSK's upgraded outlook for 2021-2026 includes sales growth of more than 7%, driven by its strong pipeline and strategic priorities[2][3][5].

Risk Factors and Black Box Warning

The black box warning associated with Jesduvroq highlights significant risks, including increased mortality, heart attacks, strokes, and thrombosis of vascular access. This warning, while supported by the majority of nephrologists, will likely influence prescribing decisions and patient selection, further impacting the drug's market uptake[1][4].

Global Regulatory Status

Jesduvroq is currently under review by the European Medicines Agency, with a decision expected in the near future. The global regulatory landscape will continue to shape the drug's availability and usage beyond the U.S. market[4].

Patient and Clinical Implications

For patients, Jesduvroq offers a new treatment option for anemia associated with CKD, but the restricted label and associated risks mean that its use will be highly selective. Clinically, the drug's mechanism of action, which stabilizes hypoxia-inducible factors (HIFs) to promote gene transcription and correct anemia, shows promise but must be balanced against the potential cardiovascular risks[1][4].

Industry Expert Insights

Industry experts and analysts note that while Jesduvroq is an innovative medicine, its market impact will be tempered by the FDA's restrictive approval and the presence of other treatment options. The cautious approach by physicians and the limited patient pool will likely result in slower sales growth than initially anticipated[1][4].

Key Takeaways

• Limited FDA Approval: Jesduvroq is approved only for adult dialysis patients with anemia caused by CKD, after at least four months on dialysis.
• Black Box Warning: The drug carries significant cardiovascular risks, which will impact prescribing decisions.
• Smaller Patient Pool: Many patients are already on ESAs, and additional risk factors limit the eligible patient pool.
• Financial Projections: Estimated sales of £364 million ($450 million), though at a slower pace than anticipated.
• GSK's Strategic Outlook: Part of a broader strategy of innovation and growth, with a strong pipeline and multiple new product launches planned.
• Global Regulatory Status: Under review by the European Medicines Agency, with a decision expected soon.

FAQs

Q: What is Jesduvroq, and what is it used for?

A: Jesduvroq, also known as daprodustat, is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved for the treatment of anemia associated with chronic kidney disease (CKD) in adult dialysis patients.

Q: What are the limitations of the FDA approval for Jesduvroq?

A: The FDA approved Jesduvroq only for patients who have been on dialysis for at least four months, and the approval includes a black box warning for increased risks of death, heart attack, stroke, and thrombosis of vascular access.

Q: How do physicians view the FDA approval of Jesduvroq?

A: Physicians are divided, with some welcoming the new treatment option but many expressing caution due to the limited label and associated black box warning.

Q: What is the estimated market impact of Jesduvroq?

A: Despite being the first new medicine for anemia treatment in over 30 years, Jesduvroq's market impact is expected to be slower due to its limited approval and the presence of other treatment options.

Q: How does Jesduvroq fit into GSK's overall business strategy?

A: Jesduvroq is part of GSK's broader strategy of innovation and growth, with a focus on Vaccines and Specialty Medicines, and a robust pipeline of new products and technologies.

Cited Sources

1. Doctors expect much lower uptake of GSK's Jesduvroq prescriptions after limitations of recent FDA approval - MMM Online
2. Annual Report 2023 - GSK
3. Strategic report 2023 - GSK
4. FDA greenlights Jesduvroq or anemia - Drug Discovery Trends
5. 2023 Annual Report on Form 20-F - GSK