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Last Updated: February 29, 2024

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BIJUVA Drug Patent Profile


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

Bijuva is a drug marketed by Mayne Pharma and is included in one NDA. There are twenty-three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-eight patent family members in twenty-one countries.

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

DrugPatentWatch® Generic Entry Outlook for Bijuva

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for BIJUVA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BIJUVA Capsules estradiol; progesterone 1 mg/100 mg 210132 1 2020-01-06

US Patents and Regulatory Information for BIJUVA

BIJUVA is protected by twenty-three US patents.

Patents protecting BIJUVA

Progesterone formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Progesterone formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Progesterone formulations having a desirable pk profile
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 BIJUVA

When does loss-of-exclusivity occur for BIJUVA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5619
Estimated Expiration: ⤷  Try a Trial

Patent: 8160
Estimated Expiration: ⤷  Try a Trial

Patent: 9872
Estimated Expiration: ⤷  Try a Trial

Patent: 7022
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 6507
Estimated Expiration: ⤷  Try a Trial

Patent: 12340589
Estimated Expiration: ⤷  Try a Trial

Patent: 13211876
Estimated Expiration: ⤷  Try a Trial

Patent: 13277233
Estimated Expiration: ⤷  Try a Trial

Patent: 13277234
Estimated Expiration: ⤷  Try a Trial

Patent: 13277235
Estimated Expiration: ⤷  Try a Trial

Patent: 13277236
Estimated Expiration: ⤷  Try a Trial

Patent: 14349132
Estimated Expiration: ⤷  Try a Trial

Patent: 15237243
Estimated Expiration: ⤷  Try a Trial

Patent: 16366200
Estimated Expiration: ⤷  Try a Trial

Patent: 17206262
Estimated Expiration: ⤷  Try a Trial

Patent: 17208300
Estimated Expiration: ⤷  Try a Trial

Patent: 17394679
Estimated Expiration: ⤷  Try a Trial

Patent: 18222947
Estimated Expiration: ⤷  Try a Trial

Patent: 18280270
Estimated Expiration: ⤷  Try a Trial

Patent: 19204653
Estimated Expiration: ⤷  Try a Trial

Patent: 19204655
Estimated Expiration: ⤷  Try a Trial

Patent: 19204658
Estimated Expiration: ⤷  Try a Trial

Patent: 21218231
Estimated Expiration: ⤷  Try a Trial

Patent: 21240253
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2014012444
Estimated Expiration: ⤷  Try a Trial

Patent: 2014018439
Estimated Expiration: ⤷  Try a Trial

Patent: 2014031824
Estimated Expiration: ⤷  Try a Trial

Patent: 2014031837
Estimated Expiration: ⤷  Try a Trial

Patent: 2014031910
Estimated Expiration: ⤷  Try a Trial

Patent: 2014031914
Estimated Expiration: ⤷  Try a Trial

Patent: 2016009008
Estimated Expiration: ⤷  Try a Trial

Patent: 2018011483
Estimated Expiration: ⤷  Try a Trial

Patent: 2019011655
Estimated Expiration: ⤷  Try a Trial

Patent: 2019025914
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 6044
Estimated Expiration: ⤷  Try a Trial

Patent: 56520
Estimated Expiration: ⤷  Try a Trial

Patent: 61346
Estimated Expiration: ⤷  Try a Trial

Patent: 76947
Estimated Expiration: ⤷  Try a Trial

Patent: 76964
Estimated Expiration: ⤷  Try a Trial

Patent: 76968
Estimated Expiration: ⤷  Try a Trial

Patent: 76977
Estimated Expiration: ⤷  Try a Trial

Patent: 26342
Estimated Expiration: ⤷  Try a Trial

Patent: 42568
Estimated Expiration: ⤷  Try a Trial

Patent: 07636
Estimated Expiration: ⤷  Try a Trial

Patent: 45024
Estimated Expiration: ⤷  Try a Trial

China

Patent: 0290793
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0210861
Estimated Expiration: ⤷  Try a Trial

Patent: 0211377
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 82584
Estimated Expiration: ⤷  Try a Trial

Patent: 06742
Estimated Expiration: ⤷  Try a Trial

Patent: 61072
Estimated Expiration: ⤷  Try a Trial

Patent: 61073
Estimated Expiration: ⤷  Try a Trial

Patent: 61233
Estimated Expiration: ⤷  Try a Trial

Patent: 61234
Estimated Expiration: ⤷  Try a Trial

Patent: 60179
Estimated Expiration: ⤷  Try a Trial

Patent: 22364
Estimated Expiration: ⤷  Try a Trial

Patent: 86514
Estimated Expiration: ⤷  Try a Trial

Patent: 48036
Estimated Expiration: ⤷  Try a Trial

Patent: 60500
Estimated Expiration: ⤷  Try a Trial

Patent: 09586
Estimated Expiration: ⤷  Try a Trial

Patent: 36133
Estimated Expiration: ⤷  Try a Trial

Patent: 09646
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1058
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 55275
Estimated Expiration: ⤷  Try a Trial

Patent: 55562
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6358
Estimated Expiration: ⤷  Try a Trial

Patent: 6359
Estimated Expiration: ⤷  Try a Trial

Patent: 5139
Estimated Expiration: ⤷  Try a Trial

Patent: 9884
Estimated Expiration: ⤷  Try a Trial

Patent: 7023
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 24393
Estimated Expiration: ⤷  Try a Trial

Patent: 85866
Estimated Expiration: ⤷  Try a Trial

Patent: 98460
Estimated Expiration: ⤷  Try a Trial

Patent: 34519
Estimated Expiration: ⤷  Try a Trial

Patent: 42334
Estimated Expiration: ⤷  Try a Trial

Patent: 42389
Estimated Expiration: ⤷  Try a Trial

Patent: 97402
Estimated Expiration: ⤷  Try a Trial

Patent: 56215
Estimated Expiration: ⤷  Try a Trial

Patent: 80672
Estimated Expiration: ⤷  Try a Trial

Patent: 82127
Estimated Expiration: ⤷  Try a Trial

Patent: 98177
Estimated Expiration: ⤷  Try a Trial

Patent: 15504924
Estimated Expiration: ⤷  Try a Trial

Patent: 15507607
Estimated Expiration: ⤷  Try a Trial

Patent: 15519405
Estimated Expiration: ⤷  Try a Trial

Patent: 15520235
Estimated Expiration: ⤷  Try a Trial

Patent: 15520236
Estimated Expiration: ⤷  Try a Trial

Patent: 15520237
Estimated Expiration: ⤷  Try a Trial

Patent: 16534025
Estimated Expiration: ⤷  Try a Trial

Patent: 17509630
Estimated Expiration: ⤷  Try a Trial

Patent: 18024685
Estimated Expiration: ⤷  Try a Trial

Patent: 18024688
Estimated Expiration: ⤷  Try a Trial

Patent: 18199711
Estimated Expiration: ⤷  Try a Trial

Patent: 18538290
Estimated Expiration: ⤷  Try a Trial

Patent: 19206540
Estimated Expiration: ⤷  Try a Trial

Patent: 19214598
Estimated Expiration: ⤷  Try a Trial

Patent: 20100642
Estimated Expiration: ⤷  Try a Trial

Patent: 20504093
Estimated Expiration: ⤷  Try a Trial

Patent: 21119155
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 82584
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 8435
Estimated Expiration: ⤷  Try a Trial

Patent: 5818
Estimated Expiration: ⤷  Try a Trial

Patent: 7596
Estimated Expiration: ⤷  Try a Trial

Patent: 14006256
Estimated Expiration: ⤷  Try a Trial

Patent: 14009093
Estimated Expiration: ⤷  Try a Trial

Patent: 14015897
Estimated Expiration: ⤷  Try a Trial

Patent: 14015898
Estimated Expiration: ⤷  Try a Trial

Patent: 14015899
Estimated Expiration: ⤷  Try a Trial

Patent: 14015900
Estimated Expiration: ⤷  Try a Trial

Patent: 16005092
Estimated Expiration: ⤷  Try a Trial

Patent: 16011706
Estimated Expiration: ⤷  Try a Trial

Patent: 18006882
Estimated Expiration: ⤷  Try a Trial

Patent: 19006513
Estimated Expiration: ⤷  Try a Trial

Patent: 20013533
Estimated Expiration: ⤷  Try a Trial

Patent: 22002614
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 82584
Estimated Expiration: ⤷  Try a Trial

Patent: 61073
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 82584
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 13888
Estimated Expiration: ⤷  Try a Trial

Patent: 40059
Estimated Expiration: ⤷  Try a Trial

Patent: 15100531
Estimated Expiration: ⤷  Try a Trial

Patent: 15100533
Estimated Expiration: ⤷  Try a Trial

Patent: 16118396
Estimated Expiration: ⤷  Try a Trial

Patent: 16136666
Estimated Expiration: ⤷  Try a Trial

Patent: 19115913
Estimated Expiration: ⤷  Try a Trial

Patent: 19139675
Estimated Expiration: ⤷  Try a Trial

Patent: 19142696
Estimated Expiration: ⤷  Try a Trial

Patent: 20140867
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 297
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1500212
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2163369
Estimated Expiration: ⤷  Try a Trial

Patent: 2177782
Estimated Expiration: ⤷  Try a Trial

Patent: 2335160
Estimated Expiration: ⤷  Try a Trial

Patent: 2488424
Estimated Expiration: ⤷  Try a Trial

Patent: 150028302
Estimated Expiration: ⤷  Try a Trial

Patent: 150032560
Estimated Expiration: ⤷  Try a Trial

Patent: 160062097
Estimated Expiration: ⤷  Try a Trial

Patent: 160137597
Estimated Expiration: ⤷  Try a Trial

Patent: 180100567
Estimated Expiration: ⤷  Try a Trial

Patent: 200013771
Estimated Expiration: ⤷  Try a Trial

Patent: 200018383
Estimated Expiration: ⤷  Try a Trial

Patent: 200128214
Estimated Expiration: ⤷  Try a Trial

Patent: 210107915
Estimated Expiration: ⤷  Try a Trial

Patent: 210148435
Estimated Expiration: ⤷  Try a Trial

Patent: 220080205
Estimated Expiration: ⤷  Try a Trial

Patent: 230021170
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 69250
Estimated Expiration: ⤷  Try a Trial

Patent: 85523
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BIJUVA around the world.

Country Patent Number Title Estimated Expiration
Spain 2885523 ⤷  Try a Trial
Australia 2015237243 Progesterone formulations ⤷  Try a Trial
Japan 6656215 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013192249 ⤷  Try a Trial
South Korea 102177782 ⤷  Try a Trial
Mexico 2019006513 FORMULACIONES Y TERAPIAS DE REEMPLAZO DE HORMONAS DE COMBINACION NATURAL. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BIJUVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2782584 132021000000197 Italy ⤷  Try a Trial PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584 LUC00245 Luxembourg ⤷  Try a Trial 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
2782584 122021000080 Germany ⤷  Try a Trial PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
2782584 2021C/558 Belgium ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--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 20210406
1453521 39/2015 Austria ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>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.