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Last Updated: April 18, 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
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 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	207504-001	Jun 15, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	AUROVELA 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	207581-001	Jun 26, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vintage Pharms Llc	GILDESS FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	077075-001	Apr 28, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996		DISCN	Yes	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
>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
Israel	186656	METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT	⤷ Try a Trial
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (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
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
1453521	CA 2016 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0136011	2000C/027	Belgium	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	15C0050	France	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0771217	07C0001	France	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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