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Last Updated: November 22, 2024

ORTHO TRI-CYCLEN Drug Patent Profile


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When do Ortho Tri-cyclen patents expire, and what generic alternatives are available?

Ortho Tri-cyclen is a drug marketed by Janssen Pharms and is included in two NDAs.

The generic ingredient in ORTHO TRI-CYCLEN 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.

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

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Recent Clinical Trials for ORTHO TRI-CYCLEN

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 clinical trials

US Patents and Regulatory Information for ORTHO TRI-CYCLEN

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 ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

International Patents for ORTHO TRI-CYCLEN

See the table below for patents covering ORTHO TRI-CYCLEN around the world.

Country Patent Number Title Estimated Expiration
Germany 2661002 ⤷  Sign Up
Sweden 7608407 ⤷  Sign Up
Norway 762583 ⤷  Sign Up
Sweden 7910336 ⤷  Sign Up
Japan S5214760 33OXIME OF PP17 ALPHAA ETHYNYLL199NORTESTOSTERONE ESTER AND METHOD ⤷  Sign Up
Israel 50103 3-OXIMES OF D-17A-ETHYNYL-19-NORTESTOSTERONE ESTERS,THEIR PREPARATION AND COMPOSITIONS CONTAINING THEM ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ORTHO TRI-CYCLEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 39/2015 Austria ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1380301 CA 2009 00017 Denmark ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076 49/2008 Austria ⤷  Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 93156 Luxembourg ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 15C0050 France ⤷  Sign Up 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 CA 2006 00038 Denmark ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.