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Ethinyl estradiol; norelgestromin - Generic Drug Details

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Ethinyl estradiol; norelgestromin is the generic ingredient in two branded drugs marketed by Mylan Technologies and Janssen Pharms, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-six drug master file entries for ethinyl estradiol; norelgestromin. Three suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norelgestromin

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list26
Suppliers / Packagers: see list3
Clinical Trials: see list260
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ethinyl estradiol; norelgestromin

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
Mylan Technologies
XULANE
ethinyl estradiol; norelgestromin
FILM, EXTENDED RELEASE;TRANSDERMAL200910-001Apr 16, 2014RXYes► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norelgestromin

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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Non-Orange Book Patents for Generic Ingredient: ethinyl estradiol; norelgestromin

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
6,071,531 Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen► subscribe
5,972,377 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 Ingredient: ethinyl estradiol; norelgestromin

Country Document Number Estimated Expiration
China1190351► subscribe
Czech Republic9703932► subscribe
World Intellectual Property Organization (WIPO)9640355► 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: ETHINYL ESTRADIOL; NORELGESTROMIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0001France► subscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076/01Switzerland► subscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C/GB03/025United Kingdom► subscribeSPC/GB03/025: 20040617, EXPIRES: 20170821
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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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