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ORTHO EVRA Drug Profile

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Ortho Evra is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in nineteen countries.

The generic ingredient in ORTHO EVRA is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

Summary for Tradename: ORTHO EVRA

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: ORTHO EVRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
ORTHO EVRA
ethinyl estradiol; norelgestromin
FILM, EXTENDED RELEASE;TRANSDERMAL021180-001Nov 20, 2001DISCNNo5,876,746► subscribeY ► subscribe
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Expired Patents for Tradename: ORTHO EVRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
ORTHO EVRA
ethinyl estradiol; norelgestromin
FILM, EXTENDED RELEASE;TRANSDERMAL021180-001Nov 20, 20015,876,746► subscribe
Janssen Pharms
ORTHO EVRA
ethinyl estradiol; norelgestromin
FILM, EXTENDED RELEASE;TRANSDERMAL021180-001Nov 20, 20015,972,377► subscribe
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Paragraph IV activity for: ORTHO EVRA

Drugname Dosage Strength RLD Submissiondate
norelgestromin and ethinyl estradiolTransdermal System0.15 mg/0.02 mg per 24 hoursOrtho Evra3/22/2007

Non-Orange Book Patents for Tradename: ORTHO EVRA

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
5,972,377 Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen► subscribe
6,071,531 Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen► 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 EVRA

Country Document Number Estimated Expiration
China1190351► subscribe
Austria229828► subscribe
Czech Republic292151► 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 EVRA

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
C0001France► subscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2009 00017Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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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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