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Last Updated: April 26, 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 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-five 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

See drug prices for IMVEXXY

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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

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

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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

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

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

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

Soluble estradiol capsule for vaginal insertion
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
European Patent Office 2782584 PRÉPARATIONS ET THÉRAPIES DE SUBSTITUTION POUR HORMONOTHÉRAPIE NATURELLE COMBINÉE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Try a Trial
Brazil 112019025914 composições farmacêuticas de estradiol para inserção vaginal e métodos ⤷  Try a Trial
European Patent Office 2861072 FORMULATIONS ET THÉRAPIES DE REMPLACEMENT D'HORMONES DE COMBINAISON NATURELLE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Try a Trial
European Patent Office 3936133 PRÉPARATIONS ET THÉRAPIES DE SUBSTITUTION POUR HORMONOTHÉRAPIE NATURELLE COMBINÉE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IMVEXXY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 49/2008 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
2782584 21C1058 France ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
0136011 C00136011/03 Switzerland ⤷  Try a Trial PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
1453521 122015000093 Germany ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
>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.