Viewing data from:

TASIMELTEON

ANDA

TASIMELTEON | A211607 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: HETLIOZ(TE code: AB)

Hatch-Waxman Litigation

5 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Vanda Pharmaceuticals Inc. v. Apotex Inc., et al. 1:2020cv01333 2 patentsANDA 211607tasimelteon	D. Del.	2020-10-01	Terminated 2022-12-14	—
Vanda Pharmaceuticals Inc. v. Apotex Inc. et al 1:2020cv00083 1 patentANDA 211607tasimelteon	D. Del.	2020-01-21	Terminated 2022-12-14	—
Vanda Pharmaceuticals Inc. v. Apotex Inc. et al 1:2019cv02375 1 patentANDA 211607tasimelteon	D. Del.	2019-12-30	Terminated 2022-12-14	—
Vanda Pharmaceuticals Inc. v. Apotex Inc. et al 1:2019cv00685 1 patentANDA 211607tasimelteon	D. Del.	2019-04-12	Terminated 2022-12-14	—
Vanda Pharmaceuticals Inc. v. Apotex Inc. et al 1:2018cv00689 6 patentsANDA 211607tasimelteon	D. Del.	2018-05-07	Terminated 2022-12-14	—

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

API Supply Chain3 active DMFs

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

APOTEX INCTASIMELTEON

DMF 318432017

MSN LIFE SCIENCES PRIVATE LTDTASIMELTEON

DMF 319482017

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDTASIMELTEON

DMF 320772017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 17, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 20, 2022

No patent or exclusivity listings for this strength.