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NDA

SILDENAFIL CITRATE | N214952 | CMP DEVELOPMENT LLC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Dec. 24, 2038

Dec. 24, 2038

Dec. 24, 2038

Dec. 24, 2038

Dec. 24, 2038

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 1, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/ML

RLD

5 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Apr 28, 2023

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
11337979	Dec 24, 2038	—	—	Yes	—
11464778	Dec 24, 2038	—	—	Yes	—
11759468	Dec 24, 2038	—	—	Yes	—
12005062	Dec 24, 2038	—	—	Yes	—
12186321	Dec 24, 2038	—	—	Yes	—