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NORLUTIN

NDA

NORETHINDRONE | N010895 | PARKE DAVIS DIV WARNER LAMBERT CO

1 strength0 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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Apothecon FDA-1994-P-0168 · 3 docket documents Apothecon, a Bristol-Myers Squibb Company, filed this citizen petition on December 8, 1994, requesting that the FDA amend its list of drugs suitable for abbreviated new drug applications to include 1 mg and 2.5 mg norethindrone tablets, which would permit acceptance of ANDAs for these dosage strengt	Other	2017-05-05	Denied	Apothecon
Warner Chilcott - Citizen Petition FDA-2008-P-0587 · 3 docket documents Warner Chilcott Company, Inc. submitted this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any ANDA relying on Loestrin 24 Fe Tablets (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg with ferrous fumarate, NDA 21-871) as the re	505(q)	2008-12-11	Granted	—
Citizen Petition from Warner Chilcott Inc. FDA-2007-P-0171 · 5 docket documents Warner Chilcott Inc. filed this petition requesting that the Food and Drug Administration refrain from approving abbreviated new drug applications for 0.4 mg Norethindrone and 35 µg Ethinyl Estradiol chewable tablets unless applicants demonstrate bioequivalence to both Ovcon-35 Oral Tablets and Femc	505(q) Stay Request	2008-05-06	Denied	Warner Chilcott Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

52 trials from ClinicalTrials.gov, 42 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus NCT00006133	N/A	Completed	National Center for Research Resources (NCRR)	970	2000-06
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions NCT01340625	Phase 1	Completed	Teva Pharmaceuticals USA	36	2006-12 → 2007-01
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception NCT01667978	N/A	Completed	University of Southern California	35	2012-06 → 2014-09
Study of Safety and Efficacy of an Oral Contraceptive NCT00932321	Phase 3	Completed	Warner Chilcott	938	2004-01 → 2004-11
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)NCT02691494	Phase 3	Completed	AbbVie	378	2016-02-03 → 2019-01-23
LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids NCT03049735	Phase 3	Completed	Myovant Sciences GmbH	388	2017-04-26 → 2020-08-24
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers NCT03856970	Phase 1	Completed	Ironwood Pharmaceuticals, Inc.	87	2019-03-11 → 2019-07-03
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions NCT01181726	Phase 1	Completed	Teva Pharmaceuticals USA	40	2007-01 → 2007-02
A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists NCT01209143	Phase 1	Completed	Genentech, Inc.	52	2010-11 → 2012-03
Ovulation Incidence in Oral Contraceptive Users NCT03106454	Phase 3	Completed	University of Southern California	58	2014-08 → 2024-01-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs9 inactive

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

DR REDDYS LABORATORIES LTDNORETHINDRONE

DMF 2401957

BAYER AGNORETHINDRONE

DMF 27261976

ASPEN OSS BVNORETHINDRONE

DMF 38491980

LUPIN LTDNORETHINDRONE USP

DMF 225052009

VALDEPHARMNORETHINDRONE

DMF 244162011

NAARI PTE LTDNORETHINDRONE

DMF 358032021

ARESKO LIFE SCIENCES PRIVATE LTDNORETHINDRONE USP

DMF 422272025

ROUSSEL CORPInactiveNORETHINDRONE

DMF 19201972

MITSUBISHI CHEMICAL CORPInactiveNORETHINDRONE, BULK

DMF 29831977

GEDEON RICHTER LTDInactiveNORETHINDRONE 1 MG. AND MESTRANOL 0.05 MG. TABLETS IN BULK

DMF 66391986

GEDEON RICHTER LTDInactiveNORETHINDRONE 1 MG. AND ETHINYL ESTRADIOL 0.035 MG. USP TABS.

DMF 66601986

GEDEON RICHTER LTDInactiveNORETHINDRONE 0.5 MG. AND ETHINYL ESTRADIOL 0.035

DMF 73321988

GEDEON RICHTER LTDInactiveNORETHINDRONE 0.75 MG. AND ETHINYL ESTRADIOL 0.035 MG. TABLET

DMF 74661988

STOLLE RESEARCH AND DEVELOPMENT CORPInactiveNORETHINDRONE INJECTABLE MICROSPHERES - CINCINNATI, OHIO

DMF 75881988

ROUSSELL UCLAFInactiveNORETHINDRONE

DMF 82391989

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTDInactiveNORETHINDRONE

DMF 241762010

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

Products (1)

#002 — 5MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.