SAMSCA Drug Patent Profile

When do Samsca patents expire, 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	022275-001	May 19, 2009	5,258,510
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-003	May 19, 2009	5,753,677
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	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	5,753,677

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
Canada	2689467
Cyprus	1112496
Australia	630284
Netherlands	300408
Denmark	1919874
Japan	5046587
Germany	69026708

Supplementary Protection Certificates for SAMSCA

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	300408	Netherlands		300408, 20101018, EXPIRES: 20151017
0450097	CA 2009 00031	Denmark
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

Market Dynamics and Financial Trajectory for SAMSCA (Tolvaptan)

Last updated: December 28, 2025

Executive Summary

SAMSCA (tolvaptan), a vasopressin V2 receptor antagonist developed by Otsuka Pharmaceutical and marketed by Vivus, is primarily indicated for the treatment of euvolemic and hypervolemic hyponatremia, notably in syndrome of inappropriate antidiuretic hormone secretion (SIADH). Its innovative mechanism offers a pivotal solution where traditional therapies fall short, propelling its growth prospects. This analysis evaluates the current market landscape, key drivers, competitive environment, revenue trajectory, and regulatory considerations shaping SAMSCA's financial future.

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What Are the Pharmacological and Clinical Highlights of SAMSCA?

Aspect	Details
Active Ingredient	Tolvaptan
Mechanism of Action	Selectively antagonizes vasopressin V2 receptors, promoting free water excretion without electrolyte loss.
Indications	Hyponatremia associated with SIADH, heart failure, cirrhosis, and autosomal dominant polycystic kidney disease (ADPKD) (FDA-approved in 2018 for ADPKD).
FDA Approval Dates	2013 (hyponatremia), 2018 (ADPKD)
Pricing and Reimbursement	Approximate annual cost: $3,500–$4,000 per patient (varies by indication and payer)

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Market Dynamics: Key Drivers and Challenges

What Are the Primary Market Drivers?

1. Increasing Incidence of Hyponatremia

   • Hyponatremia affects an estimated 8-10% of hospitalized patients, with higher prevalence in critically ill and elderly populations.
   • Co-morbid conditions like SIADH, heart failure, and cirrhosis drive demand for effective therapies.

2. Approval for ADPKD Significantly Expands Market

   • Since FDA approval in 2018, tolvaptan became the first disease-modifying therapy for ADPKD, targeting a market valued at approximately $1.2 billion globally in 2022.
   • Prevalence of ADPKD estimated at 12.5 million globally; U.S. alone has around 600,000 diagnosed cases.

3. Growing Adoption of Personalized Medicine and Oral Therapies

   • Shift away from infusion-based or restrictive sodium management enhances SAMSCA's competitiveness.
   • Preference for outpatient, easy-to-administer drugs supports increased utilization.

4. Reimbursement and Healthcare Policy Factors

   • Favorable coverage policies in major markets (U.S., Europe) underpin accessibility.
   • Incentives for early intervention in chronic conditions support long-term therapy adoption.

What Are the Challenges Facing SAMSCA's Market Penetration?

• Safety Concerns and Regulatory Warnings

  • Risk of hepatotoxicity led FDA to include black box warnings and Risk Evaluation and Mitigation Strategies (REMS) programs, impacting prescribing volume.
  • Liver function monitoring is mandatory, complicating use in some healthcare settings.

• Cost and Reimbursement Hurdles

  • High drug costs (~$3,600/month) may restrict access among uninsured or underinsured populations.
  • Payer reluctance can limit early adoption.

• Competition from Alternative and Off-label Treatments

  • Conventional fluid restriction remains first-line due to safety profile; off-label options include oral urea and demeclocycline.
  • Emerging therapies and diagnostic advancements could further challenge tolvaptan use.

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Financial Trajectory: Revenue and Sales Outlook

Current Sales Performance

Year	Estimated Global Sales	Key Market Share Notes
2015	~$50 million	Early adoption phase in USA
2018	~$180 million	Post-ADPKD approval, notable uptick
2021	~$300 million	Market expansion, increased awareness

Forecasted Growth Trajectory (2023–2028)

Year	Projected Sales	Growth Rate	Key Assumptions
2023	~$350 million	16.7%	Continued adoption in ADPKD, expanding SIADH usage
2024	~$420 million	20%	Broader global access, updated clinical guidelines
2025	~$500 million	19%	Integration into standard treatment protocols
2026	~$600 million	20%	Expanded clinical trials, potential new indications
2027	~$700 million	17%	Market saturation in key regions

Revenue Streams and Geographic Breakdown

Region	Share of Sales	Growth Drivers	Barriers
North America	~60%	Established market, high prevalence, reimbursement	Safety warnings, cost
Europe	~20%	Growing awareness, expanding approval	Regulatory delays
Asia-Pacific	~10%	Emerging markets, unmet needs	Limited awareness, reimbursement issues
Rest of World	~10%	Potential growth with approvals	Infrastructure, affordability

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Competitive Landscape

Competitor	Key Features	Market Position	Notable Challenges
Samsca (Otsuka/Vivus)	First-in-class vasopressin V2 antagonist	Market leader (hyponatremia), ADPKD exclusive post-2018	Safety profile, cost
Conivaptan (Vaprisol)	IV formulation for acute hyponatremia	Limited to inpatient use	Administration method
Urea (Oral)	Off-label use, inexpensive	Cost-effective, outside approved indications	Tolerability, patient compliance
Demeclocycline	Off-label SIADH, antibiotic basis	Limited by side effects	Safety concerns

Emerging therapies and biomarkers targeting hyponatremia's pathophysiology may threaten tolvaptan's dominance over the next decade.

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Regulatory and Policy Considerations

• FDA Labeling and REMS Programs
  • Liver injury risk mandates periodic monitoring; impacts prescribing practices.
• Insurance Coverage Policies
  • CMS and major private payers' reimbursement criteria influence uptake.
• Global Approvals
  • Regulatory approval in key markets like Japan, EU, China critical for revenue expansion.
• Policy Shifts Toward Value-Based Care
  • Cost-effectiveness analyses and health economics data needed to bolster adoption.

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Comparison with Alternative Hyponatremia Therapies

Therapy	Mode	Efficacy	Safety	Cost	Status
SAMSCA (tolvaptan)	Oral, V2 antagonist	High in SIADH, ADPKD	Hepatotoxicity, thirst	~$3,600/month	Approved for multiple indications
Fluid restriction	Non-pharmacologic	Variable	None	Free	First-line but limited in efficacy
Demeclocycline	Off-label	Moderate	Nephrotoxicity, photosensitivity	Low	Limited use due to safety
Urea	Oral	Effective	Palatability issues	Low	Off-label, used in select cases

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Future Outlook and Emerging Trends

Trend	Impact on SAMSCA	Timeline	Strategic Implications
New Diagnostic Tools	Improved patient selection, leading to targeted therapy	2024–2026	Invest in biomarker development
Combination Therapies	Potential for synergistic efficacy	2025–2028	Investigate complementarity with other agents
Enhanced Safety Profiles	Reducing liver risks to expand eligible patient populations	2024–2027	Innovate formulation or dosing
Global Market Expansion	Larger revenue base	2023–2030	Pursue approvals in emerging markets

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Key Takeaways

• Market Expansion via ADPKD Indication: Post-2018 approval transformed SAMSCA from a niche hyponatremia therapy into a key treatment for ADPKD, representing a significant growth vector projected to reach ~$700 million in global sales by 2027.
• Safety Profile as a Double-Edged Sword: Liver toxicity risks necessitate REMS programs that temper growth. Ongoing safety management is critical.
• Pricing and Reimbursement Challenges: High drug cost impacts accessibility; tailored reimbursement strategies are essential for sustained growth.
• Competitive Landscape Tightening: Emerging off-label treatments and novel agents threaten market share; innovation in safety and efficacy is vital.
• Regulatory Dynamics Will Shape Trajectory: Approvals in additional markets and evolving policies directly influence global expansion potential.

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5 Frequently Asked Questions

1. How does SAMSCA compare to traditional treatments for hyponatremia?

Traditional management relies on fluid restriction and correction of underlying causes. SAMSCA provides a targeted, pharmacological approach that can more rapidly correct serum sodium without significant electrolyte shifts, but safety concerns like hepatotoxicity require careful monitoring.

2. What is the significance of the ADPKD indication for SAMSCA's revenue?

Since FDA approval in 2018, ADPKD treatment with tolvaptan has become a substantial revenue driver due to the high disease prevalence and lack of disease-modifying treatments, creating a new, lucrative market segment.

3. Are there ongoing efforts to mitigate safety concerns associated with tolvaptan?

Yes. Research focuses on optimizing dosing, monitoring protocols, and developing formulations with improved safety profiles to minimize hepatotoxicity risks and expand patient eligibility.

4. What regions present the most growth opportunities?

While North America remains dominant, the Asia-Pacific region offers expansive growth prospects given rising healthcare infrastructure, increasing adoption of innovative therapies, and unmet needs.

5. What are the key factors influencing SAMSCA's financial success in the next five years?

Regulatory approvals, safety management, reimbursement policies, competitive developments, and market penetration in emerging markets will collectively shape its financial trajectory.

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References

[1] Otsuka Pharmaceutical. "SAMSCA (tolvaptan) Prescribing Information." 2013.
[2] U.S. Food and Drug Administration. "Tolvaptan (SAMSCA) for ADPKD approval letter." 2018.
[3] GlobalData. "Hyponatremia Therapeutics Market Report," 2022.
[4] FDA REMS Program for Tolvaptan. 2013–present.
[5] National Kidney Foundation. "ADPKD Prevalence and Treatment Landscape." 2021.