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Last Updated: April 25, 2024

Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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

Ethinyl estradiol; norethindrone acetate is the generic ingredient in fifty-eight branded drugs marketed by Xiromed, Slayback Pharma Llc, Amneal Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Apil, Aurobindo Pharma, Lupin Ltd, Teva Pharms Usa Inc, Vintage Pharms, Novast Labs, Teva Branded Pharm, Lupin, Barr Labs Inc, Glenmark Generics, Mylan Labs Ltd, Apotex, Vintage Pharms Llc, Glenmark Pharms, Barr, Parke Davis, and Mylan, and is included in seventy-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; norethindrone acetate has nine patent family members in seven countries.

Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ethinyl estradiol; norethindrone acetate

International Patents:	9
US Patents:	1
Tradenames:	58
Applicants:	22
NDAs:	73
Finished Product Suppliers / Packagers:	24
Clinical Trials:	13
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; norethindrone acetate
DailyMed Link:	ethinyl estradiol; norethindrone acetate at DailyMed

Recent Clinical Trials for ethinyl estradiol; norethindrone acetate

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

Sponsor	Phase
University of Virginia	Early Phase 1
Ironwood Pharmaceuticals, Inc.	Phase 1
University of Pennsylvania	Phase 3

See all ethinyl estradiol; norethindrone acetate clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	0.01MG,0.01MG;1MG,N/A	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ethinyl estradiol; norethindrone acetate

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LO LOESTRIN FE	Tablets	ethinyl estradiol; norethindrone acetate	1 mg/0.01 mg, 0.01 mg and 75 mg	022501	1	2011-04-29

US Patents and Regulatory Information for ethinyl estradiol; norethindrone acetate

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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
Barr	JUNEL 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	076381-001	May 30, 2003	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin	MIBELAS 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	206287-001	May 24, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novast Labs	LERIBANE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	203435-002	Jun 3, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	FYAVOLV	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	204213-002	Dec 10, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	202771-001	Nov 6, 2013	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	OSHIH	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	216558-001	Dec 6, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr	JUNEL FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	076081-001	Sep 18, 2003	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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; norethindrone acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	MINASTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	203667-001	May 8, 2013	⤷ Try a Trial	⤷ Try a Trial
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	⤷ Try a Trial	⤷ Try a Trial
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	⤷ Try a Trial	⤷ Try a Trial
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	LOESTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021871-001	Feb 17, 2006	⤷ Try a Trial	⤷ Try a Trial
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-002	Oct 15, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ethinyl estradiol; norethindrone acetate

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)	⤷ Try a Trial
China	104248639	Extended estrogen dosing contraceptive regimen	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006115871		⤷ Try a Trial
European Patent Office	2305266	Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen)	⤷ Try a Trial
Hong Kong	1205468	延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)	⤷ Try a Trial
China	101189015	Extended estrogen dosing contraceptive regimen	⤷ Try a Trial
Mexico	2007013137	REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ethinyl estradiol; norethindrone acetate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	49/2008	Austria	⤷ Try a Trial	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1380301	CA 2009 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	300814	Netherlands	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	CA 2006 00038	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1380301	2009C/007	Belgium	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1214076	SZ 49/2008	Austria	⤷ Try a Trial	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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