ETHINYL ESTRADIOL; NORELGESTROMIN - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for ethinyl estradiol; norelgestromin and what is the scope of freedom to operate?

Ethinyl estradiol; norelgestromin is the generic ingredient in four branded drugs marketed by Amneal, Zydus Noveltech Inc, Teva Pharms Usa, Janssen Pharms, and Mylan Technologies, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for ETHINYL ESTRADIOL; NORELGESTROMIN

US Patents:	0
Tradenames:	4
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	8
Clinical Trials:	20
DailyMed Link:	ETHINYL ESTRADIOL; NORELGESTROMIN at DailyMed

Recent Clinical Trials for ETHINYL ESTRADIOL; NORELGESTROMIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mylan Inc.	Phase 3
Mylan Technologies Inc.	Phase 3
Janssen Research & Development, LLC	Phase 4

See all ETHINYL ESTRADIOL; NORELGESTROMIN clinical trials

Pharmacology for ETHINYL ESTRADIOL; NORELGESTROMIN

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; NORELGESTROMIN

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORELGESTROMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORTHO EVRA	Transdermal System	ethinyl estradiol; norelgestromin	0.15 mg/0.02 mg per 24 hours	021180	1	2007-03-22

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORELGESTROMIN

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Noveltech Inc	ETHINYL ESTRADIOL AND NORELGESTROMIN	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	214594-001	Sep 14, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ONSURA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	213977-001	Aug 25, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ETHINYL ESTRADIOL; NORELGESTROMIN

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ETHINYL ESTRADIOL; NORELGESTROMIN

Subscribe to access the full database, or Sign Up
Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gedeon Richter Plc.	Evra	norelgestromin, ethinyl estradiol	EMEA/H/C/000410 Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.	Authorised	no	no	no	2002-08-22
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.