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Last Updated: November 21, 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-four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-one 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 three 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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Summary for BIJUVA
International Patents:171
US Patents:24
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Drug Prices: Drug price information for BIJUVA
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for BIJUVA
What excipients (inactive ingredients) are in BIJUVA?BIJUVA excipients list
DailyMed Link:BIJUVA at DailyMed
Drug patent expirations by year for BIJUVA
Drug Prices for BIJUVA

See drug prices for BIJUVA

Pharmacology for BIJUVA
Drug ClassEstrogen
Progesterone
Mechanism of ActionEstrogen Receptor Agonists
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-four US patents.

Patents protecting BIJUVA

Progesterone formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Natural combination hormone replacement formulations and therapies
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Progesterone formulations
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Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

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

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

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

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

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

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Natural combination hormone replacement formulations and therapies
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

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

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

Glossary
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No ⤷  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

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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
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Patent: 8160
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Patent: 9872
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Patent: 7022
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Patent: 7914
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Australia

Patent: 6507
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Patent: 12340589
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Patent: 13211876
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Patent: 13277233
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Patent: 13277234
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Patent: 13277235
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Patent: 13277236
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Patent: 14349132
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Patent: 15237243
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Patent: 16366200
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Patent: 17206262
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Patent: 17208300
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Patent: 17394679
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Patent: 18222947
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Patent: 18280270
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Patent: 19204653
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Patent: 19204655
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Patent: 19204658
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Patent: 21218231
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Patent: 21240253
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Brazil

Patent: 2014012444
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Patent: 2014018439
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Patent: 2014031824
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Patent: 2014031837
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Patent: 2014031910
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Patent: 2014031914
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Patent: 2016009008
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Patent: 2018011483
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Patent: 2019011655
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Patent: 2019025914
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Canada

Patent: 6044
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Patent: 56520
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Patent: 61346
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Patent: 76947
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Patent: 76964
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Patent: 76968
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Patent: 76977
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Patent: 26342
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Patent: 42568
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Patent: 07636
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Patent: 45024
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China

Patent: 0290793
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Croatia

Patent: 0210861
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Patent: 0211377
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European Patent Office

Patent: 82584
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Patent: 06742
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Patent: 61072
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Patent: 61073
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Patent: 61233
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Patent: 61234
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Patent: 60179
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Patent: 22364
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Patent: 86514
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Patent: 48036
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Patent: 60500
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Patent: 09586
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Patent: 36133
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Patent: 09646
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France

Patent: C1058
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Hungary

Patent: 55275
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Patent: 55562
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Israel

Patent: 6358
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Patent: 6359
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Patent: 5139
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Patent: 9884
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Patent: 7023
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Japan

Patent: 24393
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Patent: 85866
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Patent: 98460
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Patent: 34519
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Patent: 42334
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Patent: 42389
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Patent: 97402
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Patent: 56215
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Patent: 80672
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Patent: 82127
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Patent: 98177
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Patent: 15504924
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Patent: 15507607
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Patent: 15519405
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Patent: 15520235
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Patent: 15520236
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Patent: 15520237
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Patent: 16534025
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Patent: 17509630
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Patent: 18024685
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Patent: 18024688
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Patent: 18199711
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Patent: 18538290
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Patent: 19206540
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Patent: 19214598
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Patent: 20100642
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Patent: 20504093
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Patent: 21119155
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Lithuania

Patent: 82584
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Mexico

Patent: 8435
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Patent: 5818
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Patent: 7596
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Patent: 14006256
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Patent: 14009093
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Patent: 14015897
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Patent: 14015898
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Patent: 14015899
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Patent: 14015900
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Patent: 16005092
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Patent: 16011706
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Patent: 18006882
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Patent: 19006513
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Patent: 20013533
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Patent: 22002614
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Poland

Patent: 82584
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Patent: 61072
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Patent: 61073
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Portugal

Patent: 82584
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Patent: 61072
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Russian Federation

Patent: 13888
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Patent: 40059
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Patent: 15100531
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Patent: 15100533
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Patent: 16118396
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Patent: 16136666
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Patent: 19115913
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Patent: 19139675
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Patent: 19142696
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Patent: 20140867
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Serbia

Patent: 297
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South Africa

Patent: 1500212
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South Korea

Patent: 2163369
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Patent: 2177782
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Patent: 2335160
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Patent: 2488424
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Patent: 150028302
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Patent: 150032560
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Patent: 160062097
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Patent: 160137597
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Patent: 180100567
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Patent: 200013771
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Patent: 200018383
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Patent: 200128214
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Patent: 210107915
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Patent: 210148435
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Patent: 220080205
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Patent: 230021170
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Spain

Patent: 69250
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Patent: 85523
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Patent: 67709
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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
European Patent Office 3548036 ⤷  Sign Up
Japan 2019214598 天然の併用ホルモン補充療法剤及び治療 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Sign Up
South Korea 20210107915 천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Sign Up
Russian Federation 2015100531 КАПСУЛЫ С РАСТВОРИМЫМ ЭСТРАДИОЛОМ ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ ⤷  Sign Up
Russian Federation 2019142696 ЕСТЕСТВЕННАЯ КОМБИНАЦИЯ СОСТАВОВ И СПОСОБОВ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for BIJUVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 2009C/007 Belgium ⤷  Sign Up PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 300814 Netherlands ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0334429 97C0002 Belgium ⤷  Sign Up PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
>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.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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