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Last Updated: June 24, 2021

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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirteen 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-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 MAYNE PHARMA on March 14th, 1996.

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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   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>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
0398460 C300221 Netherlands   Try Before You Buy PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301 CA 2009 00017 Denmark   Try Before You Buy PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076 49/2008 Austria   Try Before You Buy PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0402407 97C0005 Belgium   Try Before You Buy PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
>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

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