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LYNORAL

NDA

ETHINYL ESTRADIOL | N005490 | ORGANON USA INC

2 strengths0 unique patents0 unique exclusivities

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 Chain5 active DMFs6 inactive

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

ASPEN OSS BVETHINYL ESTRADIOL

DMF 38031980

CHEMICAL WORKS OF GEDEON RICHTER PLC DBA GEDEON RICHTER PLCETHINYL ESTRADIOL USP

DMF 57401985

LUPIN LTDETHINYL ESTRADIOL USP

DMF 225062009

VALARY LAB PRIVATE LTDETHINYL ESTRADIOL

DMF 412832025

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDETHINYL ESTRADIOL

DMF 428532025

ORGANON INCInactiveETHINYL ESTRADIOL

DMF 14311969

ROUSSELL UCLAFInactiveETHINYL ESTRADIOL

DMF 24251975

PHARMACIA AND UPJOHNInactiveETHINYL ESTRADIOL

DMF 72241987

CYGNUS INCInactiveETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM

DMF 105911993

VALDEPHARMInactiveETHINYL ESTRADIOL

DMF 249122012

CRYSTAL PHARMA SAUInactiveETHINYL ESTRADIOL

DMF 261832012

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

Products (2)

Sort:

#002 — 0.05MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 0.01MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982