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Last Updated: October 1, 2022

IMVEXXY Drug Patent Profile


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Which patents cover Imvexxy, and what generic alternatives are available?

Imvexxy is a drug marketed by Therapeuticsmd Inc and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-nine patent family members in nineteen countries.

The generic ingredient in IMVEXXY is estradiol. There are seventy-five drug master file entries for this compound. Thirty-eight 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
University Hospitals Cleveland Medical CenterPhase 4

See all IMVEXXY clinical trials

Pharmacology for IMVEXXY
Drug Class Estrogen
Mechanism of Action Estrogen 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-two US patents.

Patents protecting IMVEXXY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Soluble estradiol capsule for vaginal insertion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Soluble estradiol capsule for vaginal insertion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Soluble estradiol capsule for vaginal insertion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Soluble estradiol capsule for vaginal insertion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Soluble estradiol capsule for vaginal insertion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

Soluble estradiol capsule for vaginal insertion
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA

Vaginal inserted estradiol pharmaceutical compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 2020100642 膣内挿入用可溶性エストラジオールカプセル (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION) See Plans and Pricing
Israel 236358 תכשירים תרופתיים המכילים תחליפי הורמונים והשימוש בהם (Pharmaceutical compositions comprising hormone replacement formulations and uses thereof) See Plans and Pricing
Japan 2015519405 膣内挿入用可溶性エストラジオールカプセル See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IMVEXXY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0136011 2000C/027 Belgium See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521 C 2015 029 Romania See Plans and Pricing PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0398460 C300221 Netherlands See Plans and Pricing PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
>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.