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SELEXIPAG

ANDA

SELEXIPAG | A214414 | ALEMBIC PHARMACEUTICALS LTD

6 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: UPTRAVI(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Actelion Pharmaceuticals US, Inc. et al v. Alembic Pharmaceuticals Limited et al 1:2023cv00383 1 patentANDA 214414selexipag	D. Del.	2023-04-04	Terminated 2023-07-05	—
ACTELION PHARMACEUTICALS LTD et al v. MSN PHARMACEUTICALS INC. et al 1:2020cv03859 3 patentsANDA 214414, 214367, 214055, 214302selexipag	D.N.J.	2020-04-09	Terminated 2022-01-14	—

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

API Supply Chain10 active DMFs

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

MAITHRI DRUGS PRIVATE LTDSELEXIPAG (FORM-P)

DMF 321232017

HONOUR LAB LTDSELEXIPAG (AMORPHOUS)

DMF 330612018

MAITHRI DRUGS PRIVATE LTDSELEXIPAG (FORM-I)

DMF 335612019

APOTEX PHARMACHEM INDIA PVT LTDSELEXIPAG

DMF 338282019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSELEXIPAG

DMF 339472019

ALEMBIC PHARMACEUTICALS LTDSELEXIPAG

DMF 339742019

MAITHRI DRUGS PRIVATE LTDSELEXIPAG (FORM-III)

DMF 361552021

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDSELEXIPAG

DMF 392872023

MSN LABORATORIES PRIVATE LTDSELEXIPAG

DMF 396992024

SABA ILAC SANAYII VE TICARET ANONIM SIRKETISELEXIPAG

DMF 425642025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.