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EVAMIST Drug Profile

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Evamist is a drug marketed by Elan Pharma Intl Ltd and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug.

This drug has fifty patent family members in seventeen countries.

The generic ingredient in EVAMIST is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the estradiol profile page.

Summary for Tradename: EVAMIST

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list63
Patent Applications: see list19,678
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EVAMIST at DailyMed

Pharmacology for Tradename: EVAMIST

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elan Pharma Intl Ltd
EVAMIST
estradiol
SPRAY;TRANSDERMAL022014-001Jul 27, 2007RXYesYes6,299,900► subscribeY ► subscribe
Elan Pharma Intl Ltd
EVAMIST
estradiol
SPRAY;TRANSDERMAL022014-001Jul 27, 2007RXYesYes6,978,945► subscribeY ► subscribe
Elan Pharma Intl Ltd
EVAMIST
estradiol
SPRAY;TRANSDERMAL022014-001Jul 27, 2007RXYesYes6,818,226► subscribeY ► subscribe
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Expired Patents for Tradename: EVAMIST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Elan Pharma Intl Ltd
EVAMIST
estradiol
SPRAY;TRANSDERMAL022014-001Jul 27, 20076,299,900► subscribe
Elan Pharma Intl Ltd
EVAMIST
estradiol
SPRAY;TRANSDERMAL022014-001Jul 27, 20076,818,226► subscribe
Elan Pharma Intl Ltd
EVAMIST
estradiol
SPRAY;TRANSDERMAL022014-001Jul 27, 20076,923,983► subscribe
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Non-Orange Book Patents for Tradename: EVAMIST

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
6,916,486 Transdermal delivery of analgesics► subscribe
6,964,777 Transdermal delivery of antianxiety agents► subscribe
8,071,075Dermal penetration enhancers and drug delivery systems involving the same► 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: EVAMIST

Country Document Number Estimated Expiration
Portugal1674068► subscribe
South Korea20070046978► subscribe
Australia2035202► 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: EVAMIST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0004Belgium► subscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
C0018France► subscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
1214076/01Switzerland► subscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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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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