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Last Updated: November 19, 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
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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

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
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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
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Patent Expiration: ⤷  Sign Up

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


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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS


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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
>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
Estimated Expiration: ⤷  Sign Up

Patent: 8160
Estimated Expiration: ⤷  Sign Up

Patent: 9872
Estimated Expiration: ⤷  Sign Up

Patent: 7022
Estimated Expiration: ⤷  Sign Up

Patent: 7914
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Australia

Patent: 6507
Estimated Expiration: ⤷  Sign Up

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
Australia 2021218231 ⤷  Sign Up
South Korea 20150032560 ⤷  Sign Up
European Patent Office 3145489 FORMULATIONS D'HORMONES SUBSTITUTIVES COMBINÉES NATURELLES ET TRAITEMENT HORMONAL SUBSTITUTIF (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  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
0398460 12/2004 Austria ⤷  Sign Up PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
2782584 2021C/558 Belgium ⤷  Sign Up 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
1214076 C01214076/01 Switzerland ⤷  Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
>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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Preferred Citation:

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