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ORTHO TRI-CYCLEN LO Drug Profile

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

This drug has forty-three patent family members in twenty-five 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-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for Tradename: ORTHO TRI-CYCLEN LO

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 2002RXYes6,214,815*PED► subscribeY► subscribe
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Expired Patents for Tradename: 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-28021241-001Aug 22, 20024,530,839*PED► subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 20024,628,051*PED► subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 20024,616,006*PED► subscribe
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Non-Orange Book Patents for Tradename: ORTHO TRI-CYCLEN LO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,809,107 Neurotrophic pyrrolidines and piperidines, and related compositions and methods► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ORTHO TRI-CYCLEN LO

Country Document Number Estimated Expiration
South Africa200106006► subscribe
World Intellectual Property Organization (WIPO)0104116► subscribe
Brazil9916579► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ORTHO TRI-CYCLEN LO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00016Denmark► subscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00C/027Belgium► subscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2006 00038Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
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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 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.

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