You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 25, 2024

IMVEXXY Drug Patent Profile

✉ Email this page to a colleague

« Back to Dashboard

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.

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for IMVEXXY?
What are the global sales for IMVEXXY?
What is Average Wholesale Price for IMVEXXY?

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:	4,071
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

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
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

+ Get email alerts for changes to this table

Subscribe to access the full database, or 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
>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.

Subscribe to access the full database, or Sign Up
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
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IMVEXXY

Subscribe to access the full database, or Sign Up
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.