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Last Updated: January 27, 2020

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LOSEASONIQUE Drug Profile

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When do Loseasonique patents expire, and what generic alternatives are available?

Loseasonique is a drug marketed by Teva Branded Pharm and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-two countries.

The generic ingredient in LOSEASONIQUE is ethinyl estradiol; levonorgestrel. 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; levonorgestrel profile page.

US ANDA Litigation and Generic Entry Outlook for Loseasonique

Loseasonique was eligible for patent challenges on December 31, 1968.

There have been three 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 are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for LOSEASONIQUE
Drug Prices for LOSEASONIQUE

See drug prices for LOSEASONIQUE

Recent Litigation for LOSEASONIQUE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
TEVA WOMEN'S HEALTH, INC. v. MYLAN PHARMACEUTICALS, INC.2010-03-09
TEVA WOMEN'S HEALTH, INC. v. LUPIN, LTD.2010-01-06

See all LOSEASONIQUE litigation

Synonyms for LOSEASONIQUE
110541-57-6
18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17-alpha)-, mixt. with (17-alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol
18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17-alpha)-(+-)-, mixt. with (17-alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol
18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17-alpha)-(+-)-,mixt. with (17-alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol
37263-36-8
39366-37-5
52232-43-6
55927-62-3
70208-30-9
8056-51-7
8063-84-1
8064-50-4
AC1L2NM9
Adepal
AG 200-15
AG200-15
aless
Alesse 28
Altavera
Anna
Anteovin
aviane
AVIANE-21
Aviane-21Fe
AVIANE-28
Biphasil
Biphasil 21
Biphasil 28
C21H28O2.C20H24O2
CCRIS 7261
CRYSELLE
dl-Norgestrel mixed with ethinylestradiol
DTXSID90192569
Duoluton
Ediwal
Elifemme
ENPRESSE-21
ENPRESSE-28
Ethinyl estradiol mixed with norgestrel
Ethinyl estradiol mixture with levonorgestrel
Ethinyl estradiol mixture with norgestrel
ETHINYL ESTRADIOL-NORGESTREL COMBINATION
ethinyl estradiol, levonorgestrel drug combination
Ethinyl estradiol/levonorgestrel
Ethinylestradiol - levonorgestrel mixt
Ethinylestradiol - levonorgestrel mixt.
Ethinylestradiol mixed with dl-norgestrel
Ethinylestradiol mixture with Levonorgestrel
Ethinyloestradiol mixed with norgestrel
Eugynon
Eugynon 30
Femenal
Follimin
Follinett
Follinyl
Gravistat
Gynatrol
Introvale
Jolessa
LESSINA-21
LESSINA-28
LEVLITE
Levonest
Levonorgestrel - ethynylestradiol mixt
Levonorgestrel - ethynylestradiol mixt.
Levonorgestrel and Ethinyl Estradiol
Levonorgestrel and Ethinyl Estradiol tablets
Levonorgestrel-ethinyl estradiol mixt
Levonorgestrel-ethinyl estradiol mixt.
Levonorgestrel, ethinyl estradiol
Levonorgestrel/ethinyl estradiol
Levora
LEVORA 0.15/30-21
LEVORA 0.15/30-28
Lo-Femenal
LO/OVRAL-28
LOC 31
LOC 31A
Logynon
Low-ogestrel
LOW-OGESTREL-21
LOW-OGESTREL-28
LS-62088
LS-62092
Lybrel
Marlissa
Microgynon
Microgynon 30
Microvlar 30
Minidril
Minigynon
Minisiston
Neogynon
Neovlar
Neovletta
NORDETTE-21
NORDETTE-28
Nordiol
Nordiol-28
Norgestrel and Ethinyl Estradiol
Norgestrel mixed with ethinyl estradiol
Norgestrel mixed with ethinyloestradiol
Norgestrel-ethinyl estradiol
Norgestrel-Ethinyl Estradiol Combination
Norgestrel-ethynylestradiol mixt
Norgestrel-ethynylestradiol mixt.
OGESTREL 0.5/50-21
OGESTREL 0.5/50-28
Orasecron
Ovidon
Ovral 21
Ovral 28
Ovral L
OVRAL-28
Ovran
Ovranett
PC 4 (contraceptive)
Pearl Oral Contraceptive
Portia
PORTIA-21
PORTIA-28
PREVEN EMERGENCY CONTRACEPTIVE KIT
Primovlar
Pro-Duosterone
Quartette
Quasense
Rigevidon
SCHEMBL4451192
Schering PC 4
Sequilar
Sequilarum
Sequostat
SH 71121
SH D00264A
SHB 261AB
SHB 264AB
Sronyx
Stederil 30
Stediril
Stediril D
Tri-Regol
Trigynon
Trikvilar
Trinordiol
Triphasil-21
TRIPHASIL-28
Triquilar
Trisiston
Trisistone R
Trisistone-R
TRIVORA-21
TRIVORA-28
Twirla
Vienva
WL 33
WY-E 104
Paragraph IV (Patent) Challenges for LOSEASONIQUE
Tradename Dosage Ingredient NDA Submissiondate
LOSEASONIQUE TABLET;ORAL ethinyl estradiol; levonorgestrel 022262 2009-11-16

US Patents and Regulatory Information for LOSEASONIQUE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No   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 LOSEASONIQUE

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
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
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Harvard Business School
Boehringer Ingelheim
Baxter
Moodys

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