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Last Updated: July 6, 2020

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IMVEXXY Drug 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 seven patents protecting this drug.

This drug has one hundred and seven patent family members in twelve countries.

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

US ANDA Litigation and Generic Entry Outlook for Imvexxy

A generic version of IMVEXXY was approved as estradiol by MAYNE PHARMA on March 14th, 1996.

  Start Trial

Summary for IMVEXXY
Drug patent expirations by year for IMVEXXY
Drug Prices for IMVEXXY

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Pharmacology for IMVEXXY
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for IMVEXXY
Tradename Dosage Ingredient NDA Submissiondate
IMVEXXY INSERT;VAGINAL estradiol 208564 2019-12-30

US Patents and Regulatory Information for IMVEXXY

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

Supplementary Protection Certificates for IMVEXXY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 PA2009004,C0770388 Lithuania   Start Trial 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
0584952 99C0004 Belgium   Start Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0770388 SPC/GB09/026 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Boehringer Ingelheim
Baxter
Colorcon
Johnson and Johnson

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.