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Last Updated: January 23, 2020

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BIJUVA Drug Profile

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When do Bijuva patents expire, and what generic alternatives are available?

Bijuva is a drug marketed by Therapeuticsmd Inc and is included in one NDA. There are twelve patents protecting this drug.

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

The generic ingredient in BIJUVA is estradiol; progesterone. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; progesterone profile page.

US ANDA Litigation and Generic Entry Outlook for Bijuva

Bijuva was eligible for patent challenges on December 31, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 21, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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

See drug prices for BIJUVA

Generic Entry Opportunity Date for BIJUVA
Generic Entry Date for BIJUVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for BIJUVA

US Patents and Regulatory Information for BIJUVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 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 BIJUVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Merck
Johnson and Johnson
McKesson
Mallinckrodt

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