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Last Updated: April 16, 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 patent protection?

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
Anuja Dokras	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
Aurobindo Pharma	AUROVELA FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	207580-001	Jun 15, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	BLISOVI FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	201584-001	Nov 18, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Barr	TRI-LEGEST 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	076405-001	Oct 26, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novast Labs	LERIBANE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	203435-001	Jun 3, 2016	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	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	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-001	Jan 14, 2005	⤷ 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
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	⤷ 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
China	104248639	Extended estrogen dosing contraceptive regimen	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006115871		⤷ Try a Trial
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)	⤷ Try a Trial
Israel	186656	METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT	⤷ 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
>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
0398460	C300221	Netherlands	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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