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Last Updated: November 2, 2024

IMVEXXY Drug Patent Profile

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Which patents cover Imvexxy, and when can generic versions of Imvexxy launch?

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 22^nd, 1997.

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Summary for IMVEXXY

International Patents:	162
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	4,101
Drug Prices:	Drug price information for IMVEXXY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMVEXXY
What excipients (inactive ingredients) are in IMVEXXY?	IMVEXXY excipients list
DailyMed Link:	IMVEXXY at DailyMed

Drug patent expirations by year for IMVEXXY

Drug Prices for IMVEXXY

Recent Clinical Trials for IMVEXXY

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

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 3
University Hospitals Cleveland Medical Center	Phase 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-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

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

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

Vaginal inserted estradiol pharmaceutical compositions and methods
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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
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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
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

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

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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.

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Country	Patent Number	Title	Estimated Expiration
Serbia	62297	PRIRODNE KOMBINOVANE HORMONSKE SUPSTITUCIONE FORMULACIJE I TERAPIJE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)	⤷ Sign Up
Russian Federation	2019139675	ВАГИНАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭСТРАДИОЛ, И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013192251		⤷ Sign Up
Mexico	367596	TRATAMIENTOS TRANSDERMICOS DE SUSTITUCION HORMONAL. (TRANSDERMAL HORMONE REPLACEMENT THERAPIES.)	⤷ Sign Up
Japan	2018024685	天然複合ホルモン補充製剤および療法 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)	⤷ Sign Up
European Patent Office	2861073	CAPSULE D'ESTRADIOL SOLUBLE POUR INSERTION VAGINALE (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION)	⤷ Sign Up
South Korea	102177782		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IMVEXXY

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004,C0770388	Lithuania	⤷ Sign Up	PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
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
1453521	C 2015 029	Romania	⤷ Sign Up	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
2782584	LUC00245	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
1453521	CA 2016 00016	Denmark	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2782584	21C1058	France	⤷ Sign Up	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
0285237	95C0008	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
>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.