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Last Updated: January 20, 2020

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TAYTULLA Drug Profile

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When do Taytulla patents expire, and when can generic versions of Taytulla launch?

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

This drug has thirty-one patent family members in twenty-three countries.

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

US ANDA Litigation and Generic Entry Outlook for Taytulla

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Taytulla was eligible for patent challenges on December 31st, 1968.

Annual sales in 2017 were $75mm indicating the motivation for generic entry.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Drug patent expirations by year for TAYTULLA
Drug Prices for TAYTULLA

See drug prices for TAYTULLA

Drug Sales Revenue Trends for TAYTULLA

See drug sales revenues for TAYTULLA

Recent Litigation for TAYTULLA

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. Lupin Ltd.2014-01-27
Bayer Intellectual Property GMBH v. Warner Chilcott Company LLC2012-08-13

See all TAYTULLA litigation

Synonyms for TAYTULLA
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
Lo Loestrin Fe
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
Trentovlane
Tri-legest 21

US Patents and Regulatory Information for TAYTULLA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013 RX Yes Yes   Start Trial   Start Trial Y   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 TAYTULLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 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
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 15C0050 France   Start 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   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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