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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Colorcon
Medtronic
Merck
Mallinckrodt
Boehringer Ingelheim
AstraZeneca
Chubb
Covington
Cipla

Generated: November 22, 2017

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ORTHO TRI-CYCLEN LO Drug Profile

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What is the patent landscape for 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. There is one patent protecting this drug.

This drug has forty-six patent family members in twenty-six countries and twelve supplementary protection certificates in eight 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 suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
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-28021241-001Aug 22, 2002ABRXYesYes► Subscribe► 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, 2002► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► 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
MexicoPA02000330► Subscribe
Brazil9916579► Subscribe
South Africa200106006► Subscribe
Australia1936500► Subscribe
Brazil0012327► Subscribe
New Zealand512404► Subscribe
Norway321118► Subscribe
Russian Federation2225207► Subscribe
Hungary229251► Subscribe
Austria318605► 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
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Chubb
Medtronic
Deloitte
Healthtrust
Colorcon
UBS
US Department of Justice
McKesson
Julphar

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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