ETHINYL ESTRADIOL; ETONOGESTREL - Generic Drug Details

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

Ethinyl estradiol; etonogestrel is the generic ingredient in six branded drugs marketed by Amneal, Xiromed, Teva Pharms Usa Inc, Dr Reddys Labs Sa, and Organon Usa Organon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for ETHINYL ESTRADIOL; ETONOGESTREL

US Patents:	0
Tradenames:	6
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	10
Clinical Trials:	12
DailyMed Link:	ETHINYL ESTRADIOL; ETONOGESTREL at DailyMed

Recent Clinical Trials for ETHINYL ESTRADIOL; ETONOGESTREL

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Sponsor	Phase
Lupin Research Inc	Phase 2
University of Washington	Phase 1
Wits Reproductive Health and HIV Institute	Phase 1

See all ETHINYL ESTRADIOL; ETONOGESTREL clinical trials

Pharmacology for ETHINYL ESTRADIOL; ETONOGESTREL

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

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

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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; ETONOGESTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUVARING	Vaginal Ring	ethinyl estradiol; etonogestrel	0.015 mg/24 hour 0.12 mg/24 hour	021187	1	2013-06-17

US Patents and Regulatory Information for ETHINYL ESTRADIOL; ETONOGESTREL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	VERARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	207577-001	Dec 9, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	ENILLORING	ethinyl estradiol; etonogestrel	RING;VAGINAL	211157-001	Jun 29, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	ETHINYL ESTRADIOL; ETONOGESTREL	ethinyl estradiol; etonogestrel	RING;VAGINAL	204305-001	Jan 13, 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; ETONOGESTREL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	NUVARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	021187-001	Oct 3, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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