Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Harvard Business School
Dow
Mallinckrodt
Merck

Last Updated: November 17, 2019

DrugPatentWatch Database Preview

ORTHO TRI-CYCLEN LO Drug Profile

See Plans and Pricing

« Back to Dashboard

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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

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

See drug prices for ORTHO TRI-CYCLEN LO

Drug Sales Revenue Trends for ORTHO TRI-CYCLEN LO

See drug sales revenues for ORTHO TRI-CYCLEN LO

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002   Start Trial   Start Trial
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002   Start Trial   Start Trial
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002   Start Trial   Start Trial
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ORTHO TRI-CYCLEN LO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011 2000C/027 Belgium   Start Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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
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
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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
McKesson
Medtronic
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.