ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - Generic Drug Details

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What are the generic drug 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-nine branded drugs marketed by Xiromed, Wilshire Pharms Inc, Amneal Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Apil, Millicent Pr, Aurobindo Pharma, Lupin Ltd, Teva Pharms Usa Inc, Endo Operations, Novast Labs, Teva Branded Pharm, Lupin, Barr Labs Inc, Apotex, Glenmark Speclt, Barr, and Parke Davis, and is included in seventy-four 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-six 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:	59
Applicants:	19
NDAs:	74
Finished Product Suppliers / Packagers:	26
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
National Institutes of Health (NIH)	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
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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; 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
Xiromed	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	206120-001	Sep 12, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	HAILEY FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	206597-001	Nov 21, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Parke Davis	NORLESTRIN 21 1/50	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	016749-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	202741-001	Feb 20, 2015	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; 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	⤷ Sign Up	⤷ Sign Up
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	LOESTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021871-001	Feb 17, 2006	⤷ Sign Up	⤷ Sign Up
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	⤷ Sign Up	⤷ Sign Up
>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
Hong Kong	1205468	延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)	⤷ Sign Up
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)	⤷ Sign Up
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)	⤷ Sign Up
China	104248639	Extended estrogen dosing contraceptive regimen	⤷ Sign Up
>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	⤷ Sign Up	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1380301	2009C/007	Belgium	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0771217	07C0001	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0136011	2000C/027	Belgium	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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