Tolvaptan - Generic Drug Details

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

Tolvaptan is the generic ingredient in three branded drugs marketed by Otsuka, Alkem Labs Ltd, Apotex, Endo Operations, Hetero Labs Ltd V, and MSN, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tolvaptan has eighty-six patent family members in twenty-four countries.

There are eight drug master file entries for tolvaptan. Six suppliers are listed for this compound.

Summary for tolvaptan

International Patents:	86
US Patents:	2
Tradenames:	3
Applicants:	6
NDAs:	7
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	93
Patent Applications:	1,870
Drug Prices:	Drug price trends for tolvaptan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tolvaptan
What excipients (inactive ingredients) are in tolvaptan?	tolvaptan excipients list
DailyMed Link:	tolvaptan at DailyMed

See drug prices for tolvaptan

Recent Clinical Trials for tolvaptan

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

Sponsor	Phase
University Medical Center Groningen	Phase 3
University of Colorado, Denver	Phase 2
University of Maryland	Phase 2

See all tolvaptan clinical trials

Pharmacology for tolvaptan

Drug Class	Vasopressin V2 Receptor Antagonist
Mechanism of Action	Vasopressin V2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for tolvaptan

C03XA	Vasopressin antagonists
C03X	OTHER DIURETICS
C03	DIURETICS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for TOLVAPTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JYNARQUE	Tablets	tolvaptan	15 mg, 30 mg, 45 mg, 60 mg, 90 mg	204441	1	2021-04-08
SAMSCA	Tablets	tolvaptan	60 mg	022275	1	2018-03-26
SAMSCA	Tablets	tolvaptan	15 mg	022275	1	2013-10-10
SAMSCA	Tablets	tolvaptan	30mg	022275	1	2013-09-23

US Patents and Regulatory Information for tolvaptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018		RX	Yes	No
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018		RX	Yes	No				Y
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018		RX	Yes	No				Y

Expired US Patents for tolvaptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018

EU/EMA Drug Approvals for tolvaptan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V.	Jinarc	tolvaptan	EMEA/H/C/002788 Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.	Authorised	no	no	no	2015-05-27
Otsuka Pharmaceutical Netherlands B.V.	Samsca	tolvaptan	EMEA/H/C/000980 Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).,	Authorised	no	no	no	2009-08-02
Accord Healthcare S.L.U.	Tolvaptan Accord	tolvaptan	EMEA/H/C/005961 Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).	Authorised	yes	no	no

International Patents for tolvaptan

Country	Patent Number	Title	Estimated Expiration
Spain	2354030
Portugal	1919874
Japan	2007091738	METHOD OF MANUFACTURING BENZOAZEPIN COMPOUND OR ITS SALT

Supplementary Protection Certificates for tolvaptan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0450097	SPC/GB09/037	United Kingdom		PRODUCT NAME: TOLVAPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/09/539/001 20090803; UK EU/1/09/539/002 20090803; UK EU/1/09/539/003 20090803; UK EU/1/09/539/004 20090803
0450097	C300408	Netherlands		PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097	09C0049	France		PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803

Tolvaptan Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tolvaptan

Introduction to Tolvaptan

Tolvaptan, a selective vasopressin V2 receptor antagonist, has been a significant player in the pharmaceutical market, particularly in the treatment of conditions such as autosomal dominant polycystic kidney disease (ADPKD), heart failure (HF), and hyponatremia (HN).

Market Growth and Forecast

The global Tolvaptan market has experienced rapid and considerable growth in recent years. Projections indicate that this substantial expansion will continue from 2023 to 2031, with the market poised for significant and noteworthy development. The positive momentum in market dynamics, driven by robust growth rates, suggests a persistent upward trend in the foreseeable future[1].

Regional Outlook

The market is expected to grow across various regions, including North America and the Asia-Pacific. In North America, the market is projected to increase significantly from 2022 to 2028, driven by increasing demand and favorable regulatory environments. Similarly, the Asia-Pacific market is anticipated to grow at a substantial CAGR during the same period, reflecting the region's growing healthcare needs and economic development[4].

Key Drivers and Opportunities

Therapeutic Applications

Tolvaptan's efficacy in treating ADPKD, HF, and HN has been a major driver of its market growth. The drug has been shown to slow the increase in total kidney volume and the decline in kidney function in ADPKD patients, making it a crucial treatment option for this rare disease[5].

Economic Impact

Economic analyses have highlighted the cost-effectiveness of tolvaptan treatment. For instance, in hospitalized patients with HF and HN, tolvaptan treatment has been associated with lower hospital-related costs due to a shorter length of stay (LOS) compared to fluid restriction (FR). This results in a cost-offset opportunity, where the decrease in hospital medical costs offsets the increase in pharmacy costs associated with tolvaptan treatment[2].

Regulatory Approvals

Tolvaptan has received regulatory approvals in multiple countries, including the UK, EU, and the US, which has expanded its market reach. For example, it was approved by NICE for the treatment of ADPKD patients with rapidly progressive disease in 2015, and similar approvals have been granted in other regions[5].

Market Challenges and Restraints

Side Effects and Monitoring

Despite its benefits, tolvaptan is associated with side effects such as liver injury, which can be a significant restraint. Lixivaptan, another vasopressin receptor antagonist, has been developed to address these concerns, as it does not exhibit the metabolite believed to cause drug-induced liver injury seen with tolvaptan[3].

Cost and Patient Selection

The high cost of tolvaptan and the need for careful patient selection to maintain a positive benefit-to-risk ratio are other challenges. The drug's effectiveness is most pronounced in patients with rapid disease progression, and its use must be balanced against the costs and monitoring requirements[5].

Financial Trajectory

Revenue Projections

The global Tolvaptan market is projected to reach significant revenue milestones by 2028. In the US, for example, the sales of JYNARQUE® (the brand name for tolvaptan) have shown steady growth, with estimated sales increasing from $60 million in 2018 to over $1 billion by 2023[3].

Cost-Effectiveness Analysis

The economic modeling of tolvaptan treatment versus fluid restriction indicates a cost-offset opportunity. While the pharmacy cost of tolvaptan treatment is higher, the reduction in hospital costs due to shorter LOS results in a net cost savings of approximately $2,296 per admission[2].

Competitive Landscape

The global Tolvaptan market is dominated by several key players, including MedChemExpress, Oakwood Chemical, Sigma-Aldrich, and Mylan Laboratories. These companies account for a significant portion of the market revenue, and their competitive strategies, including product development and pricing, play a crucial role in shaping the market dynamics[4].

Technological Trends and New Developments

Alternative Treatments

The development of alternative treatments like lixivaptan, which has a differentiated chemistry and does not exhibit the liver injury associated with tolvaptan, is a significant trend. These new developments aim to address the limitations of tolvaptan while maintaining its therapeutic benefits[3].

Clinical Trials and Extensions

Ongoing and completed clinical trials, such as the TEMPO 3:4 and REPRISE trials, continue to provide valuable data on the long-term efficacy and safety of tolvaptan. These studies have expanded our understanding of the drug's benefits and have supported its continued use in clinical practice[5].

Regional Market Insights

North America

The North American market for tolvaptan is expected to grow significantly, driven by the increasing prevalence of ADPKD and other conditions treated by the drug. Regulatory approvals and favorable reimbursement policies are also contributing factors[4].

Asia-Pacific

The Asia-Pacific region is another key market for tolvaptan, with growing healthcare demands and economic growth driving the increase in demand for the drug. Local regulatory environments and market access strategies will be crucial in this region[4].

Consumer Behaviors and Market Trends

Patient Preferences

Patient preferences for effective and safe treatments are driving the demand for tolvaptan. The drug's ability to slow disease progression and improve quality of life for ADPKD patients has made it a preferred choice among both patients and healthcare providers[5].

Healthcare Policies

Healthcare policies and reimbursement strategies play a critical role in the market dynamics of tolvaptan. Favorable policies and coverage by insurance providers have facilitated the drug's adoption and use in various regions[5].

Conclusion

The market for tolvaptan is characterized by robust growth, driven by its therapeutic efficacy, economic benefits, and regulatory approvals. However, it also faces challenges such as side effects and high costs. As the market continues to evolve, new developments and alternative treatments are expected to shape its future trajectory.

Key Takeaways

• Market Growth: The global Tolvaptan market is projected to experience significant growth from 2023 to 2031.
• Therapeutic Applications: Tolvaptan is a crucial treatment for ADPKD, HF, and HN.
• Economic Impact: Tolvaptan treatment is associated with lower hospital-related costs due to shorter LOS.
• Regulatory Approvals: Tolvaptan has received approvals in multiple countries, expanding its market reach.
• Challenges: Side effects, high costs, and the need for careful patient selection are significant challenges.
• Financial Trajectory: The market is expected to reach significant revenue milestones by 2028.

FAQs

Q: What are the primary therapeutic applications of tolvaptan?

A: Tolvaptan is primarily used to treat autosomal dominant polycystic kidney disease (ADPKD), heart failure (HF), and hyponatremia (HN).

Q: How does tolvaptan impact hospital costs for patients with HF and HN?

A: Tolvaptan treatment is associated with lower hospital-related costs due to a shorter length of stay (LOS) compared to fluid restriction (FR), resulting in a cost-offset opportunity of approximately $2,296 per admission[2].

Q: What are the regulatory approvals for tolvaptan?

A: Tolvaptan has been approved by regulatory bodies such as NICE in the UK, the Scottish Medicines Consortium (SMC), and similar approvals in the EU, US, and other countries[5].

Q: What are the potential side effects of tolvaptan?

A: Tolvaptan is associated with side effects such as liver injury, which has led to the development of alternative treatments like lixivaptan[3].

Q: How does the competitive landscape of the tolvaptan market look?

A: The market is dominated by key players including MedChemExpress, Oakwood Chemical, Sigma-Aldrich, and Mylan Laboratories, who account for a significant portion of the market revenue[4].

Sources

1. Market Research Intellect: Global Tolvaptan Market Size, Scope And Forecast Report.
2. PubMed: Economic impact of tolvaptan treatment vs. fluid restriction based on real-world registry data.
3. Centessa Pharmaceuticals: Corporate Overview.
4. 360 Research Reports: Global Tolvaptan Market – Industry Reports.
5. UK Kidney Association: Tolvaptan for ADPKD (an update).