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Last Updated: June 17, 2021

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ORTHO TRI-CYCLEN LO Drug Profile


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Which patents cover Ortho Tri-cyclen Lo, 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.

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

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 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
>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
0771217 CA 2006 00038 Denmark   Get Started Free PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521 122015000093 Germany   Get Started Free PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 15C0050 France   Get Started Free PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301 2009C/007 Belgium   Get Started Free PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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