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IDELALISIB

ANDA

IDELALISIB | A216921 | NATCO PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ZYDELIG(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. v. Natco Pharma Limited 1:2022cv01259 6 patentsANDA 216921	D. Del.	2022-09-23	Terminated 2023-08-22	—

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

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZHEJIANG LEPU PHARMACEUTICAL CO LTDIDELALISIB NON-STERILE BULK DRUG SUBSTANCES

DMF 325192018

NATCO PHARMA LTDIDELALISIB

DMF 363712021

LUPIN LTDInactiveIDELALISIB

DMF 324342018

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 2, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 17, 2026

No patent or exclusivity listings for this strength.

#002 — 150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 17, 2026