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Last Updated: January 26, 2020

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ORTHO TRI-CYCLEN LO Drug Profile

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When do Ortho Tri-cyclen Lo patents expire, and when can generic versions of Ortho Tri-cyclen Lo launch?

Ortho Tri-cyclen Lo is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has forty-six patent family members in twenty-six countries.

The generic ingredient in ORTHO TRI-CYCLEN LO is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

US ANDA Litigation and Generic Entry Outlook for Ortho Tri-cyclen Lo

Ortho Tri-cyclen Lo was eligible for patent challenges on December 31, 1968.

There have been seven 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.

Indicators of Generic Entry

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Drug patent expirations by year for ORTHO TRI-CYCLEN LO
Drug Prices for ORTHO TRI-CYCLEN LO

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Drug Sales Revenue Trends for ORTHO TRI-CYCLEN LO

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Recent Clinical Trials for ORTHO TRI-CYCLEN LO

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

SponsorPhase
Gilead SciencesPhase 1
Lexicon PharmaceuticalsPhase 1
Aegerion Pharmaceuticals, Inc.Phase 1

See all ORTHO TRI-CYCLEN LO clinical trials

Recent Litigation for ORTHO TRI-CYCLEN LO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
JANSSEN PHARMACEUTICALS, INC. v. WATSON LABORATORIES, INC.2008-10-16
ORTHO-MCNEIL PHARM v. BARR LABORATORIES

See all ORTHO TRI-CYCLEN LO litigation

Synonyms for ORTHO TRI-CYCLEN LO
18,19-Dinorpregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-, 3-oxime, (17alpha)-, mixt. with (17alpha)-19 norpregna-1,3,5(10)-trien-20-yne-3,17-diol
79871-54-8
Cilest
Estarylla
Ethinyl estradiol and norgestimate
Ethinyl estradiol mixture with norgestimate
Ethinylestradiol-norgestimate mixt
LS-187956
LS-188020
Mili
Mono-Linyah
MonoNessa
Norgestimate / ethinyl estradiol
Norgestimate and ethinyl estradiol
Norgestimate mixture with ethinyl estradiol
Norgestimate-ethinylestradiol mixt
norgestimate, ethinyl estradiol drug combination
NORGESTIMATE; ETHINYL ESTRADIOL
Ortho Cylen
ORTHO Tri Cyclen
Ortho Tri Lo
Ortho Tri-cyclen 21
Ortho Tri-cyclen 28
Ortho Tri-Cylen
Pramino
SCHEMBL6382955
Tri Cyclen
Tri prevofem
Tri-Estarylla
Tri-Linyah
Tri-Lo-Estarylla
Tri-lo-sprintec
Tri-Mili
TRI-SPRINTEC
Tricilest
Tricileste
TriNessa
TriNessa-28
Paragraph IV (Patent) Challenges for ORTHO TRI-CYCLEN LO
Tradename Dosage Ingredient NDA Submissiondate
ORTHO TRI-CYCLEN LO TABLET;ORAL-28 ethinyl estradiol; norgestimate 021241

US Patents and Regulatory Information for ORTHO TRI-CYCLEN LO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 AB 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

Expired US Patents for ORTHO TRI-CYCLEN LO

Supplementary Protection Certificates for ORTHO TRI-CYCLEN LO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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