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ORTHO-CEPT

NDA

DESOGESTREL; ETHINYL ESTRADIOL | N020301 | JANSSEN PHARMACEUTICALS 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Arnall Golden Gregory LLP FDA-2021-P-0292 · 4 docket documents Arnall Golden Gregory LLP filed this citizen petition requesting that the FDA Commissioner determine whether Ortho-Cept (desogestrel-ethinyl estradiol), approved under NDA number 020301 and held by Janssen Pharmaceuticals, was withdrawn from the market for reasons of safety or effectiveness. The pet	Other	2021-03-16	Granted	Arnall Golden Gregory LLP
Public Citizen's Health Research Group - Citizen Petition FDA-2007-P-0190 · 11 docket documents Public Citizen's Health Research Group filed a petition with the FDA pursuant to section 355(e)(3) of the Federal Food, Drug and Cosmetic Act requesting an immediate ban of third generation oral contraceptives containing desogestrel, including products such as Desogen, Mircette, Ortho-Cept, and othe	Other	2008-05-09	Denied	—

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

Clinical Trials

8 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives NCT01291004	Phase 1	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	206	2011-01-31 → 2012-03-31
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women NCT01388491	Phase 2	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	293	2011-10-31 → 2012-09-30
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment NCT01466673	Phase 4	Completed	Janssen-Cilag Ltd.,Thailand	201	2008-12 → 2010-03
The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism NCT01087879	N/A	Completed	University of Oulu	45	2007-10 → 2011-01
Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes NCT00946192	Phase 3	Completed	Massachusetts General Hospital	121	2009-05 → 2021-04
A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021 NCT00544882	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	61	2007-10-31 → 2008-03-31
Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle NCT00204438	N/A	Completed	University of Saskatchewan	45	2002-02 → 2002-12
Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents NCT00326404	Phase 3	UNKNOWN	The Hospital for Sick Children	130	2006-05 → 2009-05

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

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL-21 | Approved: Dec 14, 1992

No patent or exclusivity listings for this strength.

#002 — 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL-28 | Approved: Dec 14, 1992