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TOLVAPTAN

ANDA

TOLVAPTAN | A206119 | PH HEALTH LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SAMSCA(TE code: AB1)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc. 1:2014cv00789 2 patentsANDA 206119tolvaptan	D. Del.	2014-06-20	Terminated 2015-09-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain18 active DMFs

15 active API suppliers hold Drug Master Files for this ingredient.

HETERO DRUGS LTDTOLVAPTAN

DMF 270522013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTOLVAPTAN

DMF 271322013

APOTEX PHARMACHEM INDIA PVT LTDTOLVAPTAN

DMF 276362013

MSN LABORATORIES PRIVATE LTDTOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA]

DMF 278082013

JIANGSU HENGRUI PHARMACEUTICALS CO LTDTOLVAPTAN

DMF 278332014

MSN LABORATORIES PRIVATE LTDTOLVAPTAN [ROUTE CODE "TN"]

DMF 280102014

ALKEM LABORATORIES LTDTOLVAPTAN

DMF 320302017

LUPIN LTDTOLVAPTAN

DMF 326232019

OLON SPATOLVAPTAN

DMF 327172018

EXTROVIS AGTOLVAPTAN

DMF 343162020

AURORE LIFE SCIENCES PRIVATE LTDTOLVAPTAN

DMF 343792019

AURORE LIFE SCIENCES PRIVATE LTDTOLVAPTAN AMORPHOUS

DMF 343812019

SUN PHARMACEUTICAL INDUSTRIES LTDTOLVAPTAN

DMF 379522024

HETERO LABS LTDTOLVAPTAN POVIDONE PREMIX

DMF 394742024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTOLVAPTAN CRYSTALLINE

DMF 404692024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTOLVAPTAN AMORPHOUS

DMF 406282024

AMI LIFESCIENCES PRIVATE LTDTOLVAPTAN

DMF 408672024

ZYDUS LIFESCIENCES LTDTOLVAPTAN

DMF 420872025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 4, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG

AB1

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 15, 2022

No patent or exclusivity listings for this strength.

#002 — 30MG

AB1

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 15, 2022