Viewing data from:

TADALAFIL

ANDA

TADALAFIL | A209744 | AMNEAL PHARMACEUTICALS CO GMBH

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CIALIS(TE code: AB1)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ELI LILLY AND COMPANY et al v. AMNEAL PHARMACEUTICALS LLC 2:2018cv09071 1 patentANDA 209744tadalafil	D.N.J.	2018-05-10	Terminated 2018-11-15	—

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

API Supply Chain26 active DMFs3 inactive

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

MATRIX PHARMACORP PRIVATE LTDTADALAFIL USP

DMF 206402007

TAPI NL BVTADALAFIL

DMF 208842007

ORCHID PHARMA LTDTADALAFIL

DMF 209622007

ALIVUS LIFE SCIENCES LTDTADALAFIL

DMF 225302009

ALEMBIC PHARMACEUTICALS LTDTADALAFIL USP

DMF 227072009

SMS PHARMACEUTICALS LTDTADALAFIL

DMF 242062010

ZAKLADY FARMACEUTYCZNE POLPHARMA SATADALAFIL

DMF 245902011

MSN ORGANICS PRIVATE LTDTADALAFIL USP [ROUTE CODE - "TD"]

DMF 255132011

APITORIA PHARMA PRIVATE LTDTADALAFIL USP (NON-STERILE DRUG SUBSTANCE)

DMF 256942012

APOTEX PHARMACHEM INDIA PVT LTDTADALAFIL USP

DMF 258152012

MACLEODS PHARMACEUTICALS LTDTADALAFIL

DMF 261392013

MSN ORGANICS PRIVATE LTDTADALAFIL USP [ROUTE CODE - "TP"]

DMF 267862013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTADALAFIL USP

DMF 274792013

UNICHEM LABORATORIES LTDTADALAFIL USP

DMF 290272015

SUN PHARMACEUTICAL INDUSTRIES LTDTADALAFIL USP

DMF 293162015

ALIVUS LIFE SCIENCES LTDTADALAFIL USP (D150 PROCESS)

DMF 295952015

HONOUR LAB LTDTADALAFIL USP

DMF 297652015

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)TADALAFIL USP

DMF 306082016

SHANDONG ANXIN PHARMACEUTICAL CO LTDTADALAFIL

DMF 308602016

RUYUAN HEC PHARM CO LTDTADALAFIL NON-STERILE BULK DRUG SUBSTANCE

DMF 324532018

TOPHARMAN SHANDONG CO LTDTADALAFIL

DMF 330122018

ZHEJIANG YONGNING PHARMACEUTICAL CO LTDTADALAFIL

DMF 335022019

AZICO BIOPHORE INDIA PRIVATE LTDTADALAFIL

DMF 377512023

SHANDONG NEW TIME PHARMACEUTICAL CO LTDTADALAFIL

DMF 379152023

AMI LIFESCIENCES PRIVATE LTDTADALAFIL

DMF 379952023

SHANDONG LUNING PHARMACEUTICAL CO LTDTADALAFIL

DMF 395032024

DR REDDYS LABORATORIES LTDInactiveTADALAFIL

DMF 212092008

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveTADALAFIL (NON STERILE BULK) DRUG SUBSTANCE

DMF 227712009

AMI LIFE SCIENCES PRIVATE LTDInactiveTADALAFIL

DMF 253552011

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

Products (4)

Sort:

#001 — 2.5MG

AB1

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 26, 2019

No patent or exclusivity listings for this strength.

#002 — 5MG

AB1

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2019

#003 — 10MG

AB1

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2019

#004 — 20MG

AB1

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2019