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AFATINIB DIMALEATE

ANDA

AFATINIB DIMALEATE | A210750 | HETERO LABS LTD UNIT V

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: GILOTRIF(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. et al v. HETERO USA INC. et al 3:2017cv07923 1 patentANDA 210750afatinib	D.N.J.	2017-10-05	Terminated 2018-05-02	—

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

API Supply Chain8 active DMFs1 inactive

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

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDAFATINIB DIMALEATE NON-STERILE DRUG SUBSTANCE

DMF 428322025

MSN LABORATORIES PRIVATE LTDAFATINIB DIMALEATE MONOHYDRATE (FORM-R)

DMF 312852016

TAPI NL BVAFATINIB DIMALEATE

DMF 313022017

SUN PHARMACEUTICAL INDUSTRIES LTDAFATINIB DIMALEATE

DMF 315152017

HETERO LABS LTDAFATINIB DIMALEATE

DMF 316112017

ALEMBIC PHARMACEUTICALS LTDAFATINIB DIMALEATE

DMF 318482017

SHANDONG ANHONG PHARMACEUTICAL CO LTDAFATINIB DIMALEATE

DMF 330802019

HETERO LABS LTDAFATINIB DIMALEATE (FORM A)

DMF 371112022

FRESENIUS KABI ONCOLOGY LTDInactiveAFATINIB DIMALEATE

DMF 309272016

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

Products (3)

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#001 — EQ 20MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 14, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 14, 2026

#003 — EQ 40MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 14, 2026