TOP > News Release > Otsuka Pharmaceutical Factory launches a vasopressin V₂-receptor antagonist "Tolvaptan OD tablets 7.5 mg Otsuka"

June 17, 2022

Otsuka Pharmaceutical Factory launches a vasopressin V₂-receptor antagonist "Tolvaptan OD tablets 7.5 mg Otsuka"

Otsuka Pharmaceutical Factory, Inc. (Head Office: Naruto, Tokushima, Japan; President and Representative Director: Shinichi Ogasawara; "OPF") announces that "Tolvaptan OD tablets 7.5 mg Otsuka" (nonproprietary name: tolvaptan), a vasopressin V2-receptor antagonist, has been listed in the National Health Insurance (NHI) drug price list and launched today. Tolvaptan received regulatory approval on February 15, 2022.

Tolvaptan is an authorized generic drug with the same drug substance and additives manufactured using the same methods in the same factory as "Samsca® OD tablets 7.5 mg," which is a new dosage form of the vasopressin V2-receptor antagonist "Samsca®." Samsca was discovered and developed by our group company Otsuka Pharmaceutical Co., Ltd. (Head office: Tokyo, Japan; President and Representative Director: Makoto Inoue) and launched in December 2010.

Tolvaptan is a therapeutic agent that selectively blocks the binding of vasopressin to the V2-receptors in the collecting duct of the kidney, thereby increasing the excretion of free water and reducing the re-absorption of water from urine into the blood without directly affecting the excretion of sodium and other electrolytes. Tolvaptan was launched for the treatment of excess water retention in patients with hepatic cirrhosis when the treatment with other diuretics including loop diuretics is ineffective.

OPF, as a leading IV solution company, has an extensive network from acute care hospitals to home health care through regular visits to various clinical departments. We will continue to contribute to patients and healthcare professionals by providing products and detailed information.

Based on the corporate philosophy of "Otsuka-people creating new products for better health worldwide," the Otsuka Group is dedicated to contributing to the health of people around the world.

Product Information

Brand name

Tolvaptan OD tablets 7.5 mg Otsuka

Generic name

Tolvaptan

Indications

Treatment of excess water retention in patients with hepatic cirrhosis when the treatment with other diuretics including loop diuretics is ineffective.

Dosage and

administration

The usual adult dosage is 7.5 mg of tolvaptan administered orally once per day.

Packaging

[PTP] 20 tablets (10 tablets × 2), [PTP] 100 tablets (10 tablets × 10)

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Date of approval for manufacture and sale

February 15, 2022

Date of NHI drug price listing

June 17, 2022

Date of launch

June 17, 2022

Price

491.60 yen/tablet

Manufactured and distributed by

Otsuka Pharmaceutical Factory, Inc.

Comarketed by

Otsuka Pharmaceutical Co., Ltd.


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