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. Six 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:	101
Clinical Trials:	37
Patent Applications:	1,262
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
Otsuka Pharmaceutical Vietnam	N/A
Gia Dinh People Hospital	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	AB	RX	Yes	No	8,501,730			Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-002	May 19, 2009	AB	RX	Yes	Yes	10,905,694		Y
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275-001	May 19, 2009	AB	RX	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

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/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 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:

Austria

China

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Israel

Japan

Poland

Portugal

Slovenia

South Korea

Spain

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
Japan	2014139203	METHOD OF PRODUCING BENZOAZEPINE COMPOUND OR SALT THEREOF
Spain	2354030
Poland	2251319

Supplementary Protection Certificates for SAMSCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0450097	09C0049	France		PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 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

SAMSCA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Samsca

Introduction

Samsca, also known as tolvaptan, is a selective vasopressin V2-receptor antagonist developed by Otsuka Pharmaceutical Co., Ltd. It is used to treat various medical conditions, including hyponatremia (abnormally low sodium levels in the blood) caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH), and autosomal dominant polycystic kidney disease (ADPKD). Here, we delve into the market dynamics and financial trajectory of Samsca.

Clinical Efficacy and Indications

Samsca has demonstrated significant clinical efficacy in treating patients with low sodium levels due to SIADH and other conditions such as liver and heart problems. Studies have shown that Samsca effectively increases sodium levels in these patients, with more pronounced effects in those with SIADH compared to those with liver or heart issues[1].

Market Approval and Launch

Samsca has been approved and launched in several regions, including the United States, Europe, and Japan. In the U.S., it was launched under the brand name JYNARQUE for the treatment of ADPKD in May 2018. In Europe, it is marketed as JINARC for the same indication[3].

Market Performance and Revenue Growth

Samsca has been a significant contributor to Otsuka's revenue growth. During the Third Medium-Term Management Plan (2019-2023), Samsca/JINARC/JYNARQUE saw substantial revenue increases. In fiscal 2019, revenue from these products rose by 65.1%, outperforming plan targets and contributing significantly to the company's consolidated performance[3].

Global Expansion

The drug has been launched in approximately 20 countries and has been prescribed to around 5,800 patients with ADPKD. This global expansion has been a key factor in its revenue growth, with prescriptions increasing due to efforts in raising disease awareness and promoting proper use guidelines[3].

Financial Trajectory

Revenue Contribution

Samsca/JINARC/JYNARQUE is one of the four global products that drive Otsuka's performance, alongside ABILIFY MAINTENA, REXULTI, and LONSURF. In 2019, the revenue from these products, including Samsca, rose by 34.9% from the previous year, significantly contributing to the company's growth[3].

Medium-Term Management Plans

Under Otsuka's Third Medium-Term Management Plan, Samsca continued to be a growth driver. The company aimed to maximize the value of existing businesses and create new value, with Samsca playing a crucial role in this strategy. For the Fourth Medium-Term Management Plan (2024-2028), Otsuka plans to further accelerate growth, targeting increased revenue and expanding into new therapeutic areas[3][4].

Regulatory Considerations

FDA Restrictions

In 2013, the FDA limited the duration and usage of Samsca due to concerns about possible liver injury. The drug should not be used for longer than 30 days and should not be used in patients with underlying liver disease or in those who are at increased risk of liver injury[5].

Market Dynamics and Competition

Therapeutic Franchises

Samsca operates within the therapeutic franchises of Otsuka, which include treatments for psychiatric, neurological, and renal conditions. The company's strategy to diversify its revenue structure and strengthen its therapeutic franchises has helped Samsca maintain a competitive edge in the market[2][3].

Disease Awareness and Education

Efforts to raise disease awareness, particularly for ADPKD, have been instrumental in increasing prescriptions for Samsca. Otsuka's activities in promoting proper use guidelines and making clinical trial data available have helped in expanding the drug's market reach[3].

Challenges and Opportunities

Business Environment

The healthcare industry is undergoing significant changes, including advances in basic science, increased focus on treatment costs, and the aging of populations. These changes present both challenges and opportunities for Samsca. Otsuka's ability to adapt to these changes and invest in new technologies and science will be crucial for the drug's continued success[4].

Expansion into New Areas

Otsuka is exploring new therapeutic areas and modalities, which could provide additional opportunities for Samsca. For example, the company is working on an ultrasound-based renal denervation system, which could address unmet needs in hypertension treatment and further expand Samsca's market[4].

Key Takeaways

• Clinical Efficacy: Samsca is effective in treating hyponatremia and ADPKD, with significant clinical trial data supporting its use.
• Market Approval and Launch: Approved and launched in multiple regions, including the U.S. and Europe.
• Revenue Growth: Substantial revenue increases, contributing significantly to Otsuka's consolidated performance.
• Global Expansion: Launched in approximately 20 countries, with increasing prescriptions due to disease awareness efforts.
• Regulatory Considerations: FDA restrictions limit usage to 30 days due to potential liver injury risks.
• Market Dynamics: Strong therapeutic franchises and ongoing efforts in disease awareness and education support its market position.

FAQs

What is Samsca used for?

Samsca (tolvaptan) is used to treat hyponatremia (low sodium levels in the blood) caused by SIADH and other conditions, as well as autosomal dominant polycystic kidney disease (ADPKD).

How effective is Samsca in treating hyponatremia?

Studies have shown that Samsca effectively increases sodium levels in patients with hyponatremia, particularly those with SIADH, with significant improvements observed within days of treatment[1].

What are the common side effects of Samsca?

Common side effects include thirst, nausea, and rapid increases in sodium levels[1].

Are there any regulatory restrictions on the use of Samsca?

Yes, the FDA has limited the use of Samsca to no more than 30 days due to potential liver injury risks[5].

How has Samsca contributed to Otsuka's revenue?

Samsca has been a significant contributor to Otsuka's revenue growth, with substantial increases in revenue during the Third Medium-Term Management Plan[3].

Sources

1. European Medicines Agency: Samsca | European Medicines Agency (EMA)
2. Otsuka Holdings Co., Ltd.: Integrated Report 2018
3. Otsuka Holdings Co., Ltd.: Five-Year Growth Phase (2019–2023)
4. Otsuka Holdings Co., Ltd.: Integrated Report 2022
5. FDA: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury