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Last Updated: November 25, 2024

imvexxy Drug Patent Profile


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When do Imvexxy patents expire, and what generic alternatives are available?

Imvexxy is a drug marketed by Mayne Pharma and is included in one NDA. There are twenty patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-two patent family members in twenty-one countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Imvexxy

A generic version of imvexxy was approved as estradiol by BARR LABS INC on October 22nd, 1997.

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Drug patent expirations by year for imvexxy
Drug Prices for imvexxy

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Recent Clinical Trials for imvexxy

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Teva Pharmaceuticals USAPhase 3
University Hospitals Cleveland Medical CenterPhase 4

See all imvexxy clinical trials

Pharmacology for imvexxy
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for IMVEXXY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
IMVEXXY Vaginal Inserts estradiol 4 mcg and 10 mcg 208564 1 2019-12-30

US Patents and Regulatory Information for imvexxy

imvexxy is protected by thirty-four US patents.

Patents protecting imvexxy

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Soluble estradiol capsule for vaginal insertion
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Patent Expiration: ⤷  Sign Up

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for imvexxy

See the table below for patents covering imvexxy around the world.

Country Patent Number Title Estimated Expiration
Japan 6682127 ⤷  Sign Up
Mexico 2014006256 FORMULACIONES Y TERAPIAS DE REEMPLAZO HORMONAL DE COMBINACION NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.) ⤷  Sign Up
Spain 2885523 ⤷  Sign Up
Canada 2942568 ⤷  Sign Up
Brazil 112014031824 ⤷  Sign Up
South Korea 20210148435 ⤷  Sign Up
South Korea 20180100567 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for imvexxy

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 2009/012 Ireland ⤷  Sign Up PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0398460 04C0022 France ⤷  Sign Up PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1453521 39/2015 Austria ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0136011 2000C/027 Belgium ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521 93156 Luxembourg ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0770388 9/2009 Austria ⤷  Sign Up PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0136011 99C0003 Belgium ⤷  Sign Up PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.