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Last Updated: December 8, 2019

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LO LOESTRIN FE Drug Profile

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Which patents cover Lo Loestrin Fe, and what generic alternatives are available?

Lo Loestrin Fe is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug.

This drug has nine patent family members in seven countries.

The generic ingredient in LO LOESTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Drug patent expirations by year for LO LOESTRIN FE
Drug Prices for LO LOESTRIN FE

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Drug Sales Revenue Trends for LO LOESTRIN FE

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Recent Clinical Trials for LO LOESTRIN FE

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

SponsorPhase
Bristol-Myers SquibbPhase 1
Purdue Pharma LPPhase 1
Eisai Inc.Phase 1

See all LO LOESTRIN FE clinical trials

Recent Litigation for LO LOESTRIN FE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Warner Chilcott Company, LLC v. Amneal Pharmaceuticals, LLC2014-01-30
Warner Chilcott Company, LLC v. Lupin Ltd.2014-01-27

See all LO LOESTRIN FE litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2015-02-03

See all LO LOESTRIN FE litigation

Synonyms for LO LOESTRIN FE
19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-, acetate mixed with 19-nor-17-alpha-pregna-1,3,5-(10)-trien-20-yne-3,17-diol
8015-12-1
8067-81-0
AC1L1Y7Y
Anovlar 21
Aurovela 1.5/30
Controvlar
Cumorit
Econ 30
ESTROSTEP 21
Etalontin
Ethinyl estradiol mixture with norethindrone acetate
Ethinyl oestradiol mixed with norethisterone acetate
Ethinylestradiol and norethindrone acetate
Gyn-Anovlar
Gynonlar
Gynonlar 21
Hailey Fe 1/20
Junel 1.5/30
Junel 1/20
Lo Loestrin
LOESTRIN 21 1.5/30
LOESTRIN 21 1/20
LOESTRIN FE 1/20
Microgestin
Microgestin 1.5/30
Microgestin 1/20
Minastrin 24 Fe
Neorlest
Norethindrone acetate and ethinyl estradiol
Norethindrone acetate and ethinylestradiol
Norethisterone acetate mixed with ethinyl oestradiol
NORLESTRIN 21 1/50
NORLESTRIN 21 2.5/50
NORLESTRIN 28 1/50
Primodos
SCHEMBL2523461
Sinovula
Taytulla
Trentovlane
Tri-legest 21
Paragraph IV (Patent) Challenges for LO LOESTRIN FE
Tradename Dosage Ingredient NDA Submissiondate
LO LOESTRIN FE TABLET;ORAL ethinyl estradiol; norethindrone acetate 022501 2011-04-29

US Patents and Regulatory Information for LO LOESTRIN FE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for LO LOESTRIN FE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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