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ASENAPINE MALEATE

ANDA

ASENAPINE MALEATE | A206107 | SIGMAPHARM LABORATORIES LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SAPHRIS(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Forest Laboratories LLC et al v. Sigmapharm Laboratories LLC et al 1:2014cv01119 2 patentsANDA 206107asenapine maleate	D. Del.	2014-09-03	Terminated 2020-09-14	—

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

API Supply Chain10 active DMFs3 inactive

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

DR REDDYS LABORATORIES LTDASENAPINE MALEATE

DMF 257452012

OLON SPAASENAPINE MALEATE

DMF 261042012

MSN ORGANICS PRIVATE LTDASENAPINE MALEATE [ROUTE CODE AN]

DMF 267852013

MSN ORGANICS PRIVATE LTDASENAPINE MALEATE [ROUTE CODE "AOI"]

DMF 269732013

MATRIX PHARMACORP PRIVATE LTDASENAPINE MALEATE

DMF 270862013

SUN PHARMACEUTICAL INDUSTRIES LTDASENAPINE MALEATE

DMF 271852013

ALEMBIC PHARMACEUTICALS LTDASENAPINE MALEATE

DMF 271942013

MEGAFINE PHARMA P LTDASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE)

DMF 272922013

SIGMAPHARM LABORATORIES LLCASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX

DMF 273002013

ASPEN OSS BVASENAPINE MALEATE

DMF 348682020

LUPIN LTDInactiveASENAPINE MALEATE (MICRONIZED)

DMF 272852013

CHEMO IBERICA SAInactiveASENAPINE MALEATE

DMF 272902013

SIGNA SA DE CVInactiveASENAPINE MALEATE

DMF 273162013

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 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Dec 10, 2020

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Dec 10, 2020