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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022014

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NDA 022014 describes EVAMIST, which is a drug marketed by Perrigo Pharma Intl and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug. Additional details are available on the EVAMIST profile page.

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

Summary for 022014

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 022014

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 022014

Suppliers and Packaging for NDA: 022014

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVAMIST estradiol SPRAY;TRANSDERMAL 022014 NDA Paddock Laboratories, LLC 0574-2067 0574-2067-00 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)
EVAMIST estradiol SPRAY;TRANSDERMAL 022014 NDA Paddock Laboratories, LLC 0574-2067 0574-2067-27 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TRANSDERMALStrength1.53MG/SPRAY
Approval Date:Jul 27, 2007TE:RLD:Yes
Patent:► SubscribePatent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN
Patent:► SubscribePatent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCCIATED WITH MENOPAUSE)
Patent:► SubscribePatent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN

Expired Orange Book Patents for NDA: 022014

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma IntlEVAMISTestradiolSPRAY;TRANSDERMAL022014-001Jul 27, 2007► Subscribe► Subscribe
Perrigo Pharma IntlEVAMISTestradiolSPRAY;TRANSDERMAL022014-001Jul 27, 2007► Subscribe► Subscribe
Perrigo Pharma IntlEVAMISTestradiolSPRAY;TRANSDERMAL022014-001Jul 27, 2007► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Citi
Cerilliant
Fish and Richardson
Julphar
Covington
Teva
Express Scripts
UBS

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