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SILDENAFIL CITRATE

ANDA

SILDENAFIL CITRATE | A202659 | HETERO LABS LTD UNIT V

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: REVATIO(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
PFIZER INC. et al v. HETERO DRUGS LTD. et al 2:2011cv04372 2 patentsANDA 202659sildenafil citrate	D.N.J.	2011-07-28	Terminated 2011-12-07	—

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

API Supply Chain17 active DMFs5 inactive

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

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDSILDENAFIL CITRATE

DMF 177782004

MATRIX PHARMACORP PRIVATE LTDSILDENAFIL CITRATE USP

DMF 190972006

CADILA PHARMACEUTICALS LTDSILDENAFIL CITRATE USP

DMF 211542007

HETERO DRUGS LTDSILDENAFIL CITRATE

DMF 216192008

TORRENT PHARMACEUTICALS LTDSILDENAFIL CITRATE

DMF 221422008

PH HEALTH LTDSILDENAFIL CITRATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 230672009

RAKS PHARMA PVT LTDSILDENAFIL CITRATE USP

DMF 235092010

MACLEODS PHARMACEUTICALS LTDSILDENAFIL CITRATE USP

DMF 237052010

ZAKLADY FARMACEUTYCZNE POLPHARMA SASILDENAFIL CITRATE

DMF 239302010

MSN ORGANICS PRIVATE LTDSILDENAFIL CITRATE USP [ROUTE CODE - "SE"]

DMF 243072010

AMOLI ORGANICS PVT LTDSILDENAFIL CITRATE USP

DMF 253112011

SMS PHARMACEUTICALS LTDSILDENAFIL CITRATE (UNIT-II)

DMF 253582011

APITORIA PHARMA PRIVATE LTDSILDENAFIL CITRATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 254242011

AZICO BIOPHORE INDIA PVT LTDSILDENAFIL CITRATE

DMF 298312015

SMS LIFESCIENCES INDIA LTDSILDENAFIL CITRATE

DMF 359142021

SICHUAN KELUN PHARMACEUTICAL CO LTDSILDENAFIL CITRATE

DMF 384632023

THE MOLECULEZSILDENAFIL CITRATE IP/BP/EP/USP

DMF 433402025

SMS PHARMACEUTICALS LTDInactiveSildenafil Citrate

DMF 212502008

DR REDDYS LABORATORIES LTDInactiveSILDENAFIL CITRATE

DMF 220372008

SIGNA SA DE CVInactiveSILDENAFIL CITRATE USP

DMF 225992009

AMOLI ORGANICS PVT LTDInactiveSILDENAFIL CITRATE FORM-II

DMF 252312011

MYLAN LABORATORIES LTDInactiveSILDENAFIL

DMF 267772012

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

Products (3)

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#001 — EQ 25MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 11, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 50MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 11, 2018

#003 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 11, 2018