SAMSCA Drug Patent Profile

Which patents cover Samsca, and what generic alternatives are available?

Samsca is a drug marketed by Otsuka and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Samsca

A generic version of SAMSCA was approved as tolvaptan by ALKEM LABS LTD on May 19^th, 2020.

Summary for SAMSCA

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	37
Patent Applications:	21
Drug Prices:	Drug price information for SAMSCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAMSCA
What excipients (inactive ingredients) are in SAMSCA?	SAMSCA excipients list
DailyMed Link:	SAMSCA at DailyMed

See drug prices for SAMSCA

Recent Clinical Trials for SAMSCA

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

Sponsor	Phase
Gia Dinh People Hospital	N/A
Otsuka Pharmaceutical Vietnam	N/A
Chinese Pulmonary Vascular Disease Research Group	N/A

See all SAMSCA clinical trials

Pharmacology for SAMSCA

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

Paragraph IV (Patent) Challenges for SAMSCA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 SAMSCA

SAMSCA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-001	May 19, 2009	AB1	RX	Yes	No	8,501,730			Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	AB1	RX	Yes	Yes	10,905,694		Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-001	May 19, 2009	AB1	RX	Yes	No	10,905,694		Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	AB1	RX	Yes	Yes	8,501,730			Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009		DISCN	Yes	No	8,501,730			Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009		DISCN	Yes	No	10,905,694		Y

Expired US Patents for SAMSCA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009	5,753,677
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	5,258,510
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009	5,258,510
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-001	May 19, 2009	5,258,510
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	5,753,677
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-001	May 19, 2009	5,753,677

EU/EMA Drug Approvals for SAMSCA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V.	Jinarc	tolvaptan	EMEA/H/C/002788Jinarc 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/000980Treatment 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/005961Tolvaptan 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 SAMSCA

When does loss-of-exclusivity occur for SAMSCA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

Cyprus

Denmark

Hong Kong

Israel

Japan

Poland

Slovenia

South Korea

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

See the table below for additional patents covering SAMSCA around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	122009000062
Israel	217446
Brazil	1100245
Japan	2014139203
Israel	202179	PHARMACEUTICAL SOLID PREPARATION COMPRISING BENZAZEPINES AND PRODUCTION METHOD THEREOF
Denmark	2251319

Supplementary Protection Certificates for SAMSCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0450097	300408	Netherlands		300408, 20101018, EXPIRES: 20151017
0450097	09C0049	France		PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
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	CA 2009 00031	Denmark

Market Dynamics and Financial Trajectory for SAMSCA (Tolvaptan)

Last updated: July 27, 2025

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Introduction

SAMSCA (tolvaptan) is a selective vasopressin V2-receptor antagonist approved by the Food and Drug Administration (FDA) in 2013 for the treatment of clinically significant hyponatremia in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH) and other causes of hyponatremia (e.g., congestive heart failure, cirrhosis). Its unique mechanism of action and targeted indication position it as a specialized therapy with distinct market dynamics. Analyzing its current and projected financial trajectory involves understanding the competitive landscape, regulatory environment, clinical utility, and market adoption patterns.

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Market Overview

The global hyponatremia treatment market, projected to reach approximately $2.3 billion by 2027 [1], is driven by increasing awareness of hyponatremia-related morbidity, aging populations, and expanding indications. SAMSCA's niche positioning within this market hinges on its ability to address complex hyponatremia cases resistant to conventional therapy. Its primary FDA-approved indication, SIADH, though specific, limits its usage to specialized settings, affecting overall market penetration.

The drug has also garnered attention for off-label use in conditions like congestive heart failure and liver cirrhosis-related hyponatremia, augmenting its market scope. However, off-label prescriptions face regulatory and reimbursement hurdles, shaping adoption rates.

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Market Dynamics

1. Competitive Landscape

SAMSCA competes directly with other vasopressin receptor antagonists, notably Lixivaptan and Vaprisol (oryzaptan)—although their market presence remains limited. Conventional treatment options, such as fluid restriction and hypertonic saline, continue to dominate due to familiarity, cost, and regulatory approval.

The emergence of novel agents and biosimilars further influences technologic and economic parameters. While no biosimilar for tolvaptan currently exists, patent expirations and ongoing clinical trials could reshape competitive dynamics in the coming years.

2. Regulatory Environment

Though FDA approval anchors SAMSCA’s market, differing regulatory pathways in regions like Europe, Japan, and China impact its global market expansion. Notably, in Europe, tolvaptan has been approved for autosomal dominant polycystic kidney disease (ADPKD) [2], diversifying its indications and potential revenue streams distinct from hyponatremia.

3. Reimbursement & Healthcare Economics

Reimbursement policies significantly influence utilization. The high cost of tolvaptan (~$3000–$4000/month in the U.S.) limits widespread use, especially given the preference for cheaper, off-label alternatives. Payers increasingly demand demonstrated cost-effectiveness, which challenges widespread adoption absent substantial clinical benefit evidence.

4. Clinical Efficacy and Safety

Clinical trials demonstrate that tolvaptan effectively normalizes serum sodium levels in hyponatremic patients [3], but safety concerns, such as hepatotoxicity and rapid sodium correction risks, restrict outpatient use and long-term therapy. These safety profiles impact prescriber confidence and market growth potential.

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Financial Trajectory

1. Revenue Trends

Since its launch in 2013, SAMSCA has experienced modest revenue growth, with peak U.S. sales approaching $300 million in 2018 [4]. Revenues plateaued due to market saturation, safety warnings, and reimbursement challenges. Post-2018, growth has been constrained, with recent estimates indicating a decline or stagnation in some markets.

2. Market Penetration Strategies

Mitsubishi Tanabe Pharma, the original developer, has focused on expanding clinical understanding and gaining approvals for additional indications, especially ADPKD. Such expansions could diversify revenue streams, reduce reliance on hyponatremia, and improve financial prospects.

3. Off-Label Use and Emerging Markets

Off-label utilization in heart failure and liver cirrhosis represents a potential growth driver, especially in emerging markets with less restrictive prescribing practices [5]. Licensing agreements and strategic collaborations could further boost sales.

4. Impact of Competitive & Regulatory Developments

Regulatory setbacks or new safety data could negatively impact revenue. Conversely, improved safety profiles, broader indications, or reduced manufacturing costs could enhance profitability.

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Future Outlook and Opportunities

The future trajectory of SAMSCA hinges on several factors:

• Expanded Indications: Clinical trials ongoing for ADPKD and heart failure treatment could lead to label expansions, significantly augmenting sales.

• Market Penetration in Emerging Economies: Growing healthcare infrastructure and off-label prescribing could elevate revenues, provided regulatory hurdles are navigated.

• New Formulations & Delivery Methods: Development of extended-release versions or combination therapy options could improve adherence and clinical outcomes, influencing market growth.

• Competitive Innovations: Next-generation vasopressin antagonists with improved safety profiles or superior efficacy could displace tolvaptan, constraining long-term revenue.

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Key Challenges

• Safety Concerns: Hepatotoxicity risks necessitate careful patient selection and monitoring, complicating outpatient use.

• Pricing & Cost-Effectiveness: High drug costs hinder uptake amidst healthcare cost containment.

• Limited Indication Breadth: Current narrow approval spectrum restricts market expansion.

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Conclusion

SAMSCA’s financial outcomes and market trajectory are intricately linked to its evolving clinical profile, regulatory landscape, and competitive environment. While initial growth has plateaued, ongoing clinical research, new indications, and strategic market penetration—especially in emerging economies—represent significant growth opportunities. However, addressing safety concerns and cost barriers remains essential to maximizing long-term revenue potential.

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Key Takeaways

• Market Saturation and Competition: SAMSCA faces limited growth within its primary FDA-approved indication due to safety concerns and high costs that restrict widespread adoption.

• Expansion Potential: New indications like ADPKD and off-label uses in heart failure and cirrhosis could diversify revenue streams if regulatory approvals are secured and safety profiles favorable.

• Pricing & Reimbursement Challenges: High monthly costs limit access, emphasizing the need for demonstrating clear clinical and economic benefits.

• Safety Profile Considerations: Hepatotoxicity remains a critical hurdle, influencing prescribing patterns and market acceptance.

• Strategic Opportunities: Market growth in emerging economies and formulation innovations could drive revenue beyond current limitations.

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FAQs

1. What are the primary factors limiting SAMSCA's market growth?
High drug costs, safety concerns, limited approved indications, and reimbursement challenges primarily hinder widespread adoption and revenue growth.

2. How might new indications impact SAMSCA’s financial trajectory?
Label expansions to conditions like ADPKD or heart failure could substantially increase sales if regulatory approvals are obtained and safety concerns managed.

3. What competitive threats does SAMSCA face?
Emerging vasopressin antagonists with better safety or efficacy profiles, biosimilars, or alternative therapies such as fluid restriction could challenge SAMSCA’s market share.

4. How important are safety concerns in shaping SAMSCA’s future?
Safety issues such as hepatotoxicity significantly influence prescriber confidence, reimbursement policies, and potential market expansion.

5. Could pricing strategies alter SAMSCA’s market outlook?
Yes; reducing costs or demonstrating cost-effectiveness through real-world evidence could improve payer reimbursement and increase patient access.

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References

[1] Grand View Research. Hyponatremia Treatment Market Size & Trends. 2021.

[2] European Medicines Agency. Tolvaptan for ADPKD approval. 2015.

[3] Schrier RW, et al. Clinical implications of Tolvaptan in hyponatremia. J Clin Med. 2016.

[4] IQVIA. Pharma Market Reports. 2019.

[5] Lauretti L, et al. Off-label use of tolvaptan in heart failure. Clin Ther. 2020.

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Note: This analysis synthesizes recent market data and clinical insights, fostering strategic business decisions for stakeholders involved with SAMSCA.