Viewing data from:

LOESTRIN 21 1/20

NDA

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | N017876 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Lachman Consultant Services Inc FDA-2014-P-1101 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA Commissioner determine whether LOESTRIN 21 1/20 (ethinyl estradiol/norethindrone acetate) Tablets, 0.02 mg/1 mg, approved under NDA 017876, was voluntarily withdrawn from the marketplace for safety or	505(q)	2014-09-03	Denied	Lachman Consultant Services Inc

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

Clinical Trials

17 trials from ClinicalTrials.gov, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism NCT00004763	Phase 2	Completed	National Center for Research Resources (NCRR)	45	1993-01
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
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
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive NCT01040845	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.	30	2007-08 → 2008-02
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325 NCT02103569	Phase 1	Completed	Bristol-Myers Squibb	20	2014-04 → 2014-07
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions NCT01344369	Phase 1	Completed	Teva Pharmaceuticals USA	36	2008-08 → 2008-09
Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.NCT00212277	Phase 3	Completed	Nobelpharma	—	2005-02 → 2007-02
Study of Bleeding With Extended Administration of an Oral Contraceptive NCT00338052	Phase 2	Completed	Warner Chilcott	207	2006-06 → 2007-05
Study of Safety and Efficacy of an Oral Contraceptive NCT00477633	Phase 3	Completed	Warner Chilcott	1,700	2007-06 → 2009-02

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jan 5, 2023	SUPPL -40	View Letter (PDF)
Jan 5, 2023	SUPPL -40	View Letter (PDF)
May 2, 2022	SUPPL -39	View Letter (PDF)
Aug 15, 2017	SUPPL -36	View Letter (PDF)
May 30, 2003	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL-21 | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.