You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 19, 2024

~ Buy the BIJUVA (estradiol; progesterone) Drug Profile, 2024 PDF Report in the Report Store ~

bijuva Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

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

< Available with Subscription >

  Sign Up

AI Research Assistant
Ask!
Questions you can ask:
  • What is the 5 year forecast for bijuva?
  • What are the global sales for bijuva?
  • What is Average Wholesale Price for bijuva?
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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Progesterone formulations
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

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


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


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

Subscribe to access the full database, or Sign Up

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
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 6507
Estimated Expiration: ⤷  Sign Up

Patent: 12340589
Estimated Expiration: ⤷  Sign Up

Patent: 13211876
Estimated Expiration: ⤷  Sign Up

Patent: 13277233
Estimated Expiration: ⤷  Sign Up

Patent: 13277234
Estimated Expiration: ⤷  Sign Up

Patent: 13277235
Estimated Expiration: ⤷  Sign Up

Patent: 13277236
Estimated Expiration: ⤷  Sign Up

Patent: 14349132
Estimated Expiration: ⤷  Sign Up

Patent: 15237243
Estimated Expiration: ⤷  Sign Up

Patent: 16366200
Estimated Expiration: ⤷  Sign Up

Patent: 17206262
Estimated Expiration: ⤷  Sign Up

Patent: 17208300
Estimated Expiration: ⤷  Sign Up

Patent: 17394679
Estimated Expiration: ⤷  Sign Up

Patent: 18222947
Estimated Expiration: ⤷  Sign Up

Patent: 18280270
Estimated Expiration: ⤷  Sign Up

Patent: 19204653
Estimated Expiration: ⤷  Sign Up

Patent: 19204655
Estimated Expiration: ⤷  Sign Up

Patent: 19204658
Estimated Expiration: ⤷  Sign Up

Patent: 21218231
Estimated Expiration: ⤷  Sign Up

Patent: 21240253
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014012444
Estimated Expiration: ⤷  Sign Up

Patent: 2014018439
Estimated Expiration: ⤷  Sign Up

Patent: 2014031824
Estimated Expiration: ⤷  Sign Up

Patent: 2014031837
Estimated Expiration: ⤷  Sign Up

Patent: 2014031910
Estimated Expiration: ⤷  Sign Up

Patent: 2014031914
Estimated Expiration: ⤷  Sign Up

Patent: 2016009008
Estimated Expiration: ⤷  Sign Up

Patent: 2018011483
Estimated Expiration: ⤷  Sign Up

Patent: 2019011655
Estimated Expiration: ⤷  Sign Up

Patent: 2019025914
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 6044
Estimated Expiration: ⤷  Sign Up

Patent: 56520
Estimated Expiration: ⤷  Sign Up

Patent: 61346
Estimated Expiration: ⤷  Sign Up

Patent: 76947
Estimated Expiration: ⤷  Sign Up

Patent: 76964
Estimated Expiration: ⤷  Sign Up

Patent: 76968
Estimated Expiration: ⤷  Sign Up

Patent: 76977
Estimated Expiration: ⤷  Sign Up

Patent: 26342
Estimated Expiration: ⤷  Sign Up

Patent: 42568
Estimated Expiration: ⤷  Sign Up

Patent: 07636
Estimated Expiration: ⤷  Sign Up

Patent: 45024
Estimated Expiration: ⤷  Sign Up

China

Patent: 0290793
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0210861
Estimated Expiration: ⤷  Sign Up

Patent: 0211377
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 82584
Estimated Expiration: ⤷  Sign Up

Patent: 06742
Estimated Expiration: ⤷  Sign Up

Patent: 61072
Estimated Expiration: ⤷  Sign Up

Patent: 61073
Estimated Expiration: ⤷  Sign Up

Patent: 61233
Estimated Expiration: ⤷  Sign Up

Patent: 61234
Estimated Expiration: ⤷  Sign Up

Patent: 60179
Estimated Expiration: ⤷  Sign Up

Patent: 22364
Estimated Expiration: ⤷  Sign Up

Patent: 86514
Estimated Expiration: ⤷  Sign Up

Patent: 48036
Estimated Expiration: ⤷  Sign Up

Patent: 60500
Estimated Expiration: ⤷  Sign Up

Patent: 09586
Estimated Expiration: ⤷  Sign Up

Patent: 36133
Estimated Expiration: ⤷  Sign Up

Patent: 09646
Estimated Expiration: ⤷  Sign Up

France

Patent: C1058
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 55275
Estimated Expiration: ⤷  Sign Up

Patent: 55562
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6358
Estimated Expiration: ⤷  Sign Up

Patent: 6359
Estimated Expiration: ⤷  Sign Up

Patent: 5139
Estimated Expiration: ⤷  Sign Up

Patent: 9884
Estimated Expiration: ⤷  Sign Up

Patent: 7023
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 24393
Estimated Expiration: ⤷  Sign Up

Patent: 85866
Estimated Expiration: ⤷  Sign Up

Patent: 98460
Estimated Expiration: ⤷  Sign Up

Patent: 34519
Estimated Expiration: ⤷  Sign Up

Patent: 42334
Estimated Expiration: ⤷  Sign Up

Patent: 42389
Estimated Expiration: ⤷  Sign Up

Patent: 97402
Estimated Expiration: ⤷  Sign Up

Patent: 56215
Estimated Expiration: ⤷  Sign Up

Patent: 80672
Estimated Expiration: ⤷  Sign Up

Patent: 82127
Estimated Expiration: ⤷  Sign Up

Patent: 98177
Estimated Expiration: ⤷  Sign Up

Patent: 15504924
Estimated Expiration: ⤷  Sign Up

Patent: 15507607
Estimated Expiration: ⤷  Sign Up

Patent: 15519405
Estimated Expiration: ⤷  Sign Up

Patent: 15520235
Estimated Expiration: ⤷  Sign Up

Patent: 15520236
Estimated Expiration: ⤷  Sign Up

Patent: 15520237
Estimated Expiration: ⤷  Sign Up

Patent: 16534025
Estimated Expiration: ⤷  Sign Up

Patent: 17509630
Estimated Expiration: ⤷  Sign Up

Patent: 18024685
Estimated Expiration: ⤷  Sign Up

Patent: 18024688
Estimated Expiration: ⤷  Sign Up

Patent: 18199711
Estimated Expiration: ⤷  Sign Up

Patent: 18538290
Estimated Expiration: ⤷  Sign Up

Patent: 19206540
Estimated Expiration: ⤷  Sign Up

Patent: 19214598
Estimated Expiration: ⤷  Sign Up

Patent: 20100642
Estimated Expiration: ⤷  Sign Up

Patent: 20504093
Estimated Expiration: ⤷  Sign Up

Patent: 21119155
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 82584
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 8435
Estimated Expiration: ⤷  Sign Up

Patent: 5818
Estimated Expiration: ⤷  Sign Up

Patent: 7596
Estimated Expiration: ⤷  Sign Up

Patent: 14006256
Estimated Expiration: ⤷  Sign Up

Patent: 14009093
Estimated Expiration: ⤷  Sign Up

Patent: 14015897
Estimated Expiration: ⤷  Sign Up

Patent: 14015898
Estimated Expiration: ⤷  Sign Up

Patent: 14015899
Estimated Expiration: ⤷  Sign Up

Patent: 14015900
Estimated Expiration: ⤷  Sign Up

Patent: 16005092
Estimated Expiration: ⤷  Sign Up

Patent: 16011706
Estimated Expiration: ⤷  Sign Up

Patent: 18006882
Estimated Expiration: ⤷  Sign Up

Patent: 19006513
Estimated Expiration: ⤷  Sign Up

Patent: 20013533
Estimated Expiration: ⤷  Sign Up

Patent: 22002614
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 82584
Estimated Expiration: ⤷  Sign Up

Patent: 61072
Estimated Expiration: ⤷  Sign Up

Patent: 61073
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 82584
Estimated Expiration: ⤷  Sign Up

Patent: 61072
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 13888
Estimated Expiration: ⤷  Sign Up

Patent: 40059
Estimated Expiration: ⤷  Sign Up

Patent: 15100531
Estimated Expiration: ⤷  Sign Up

Patent: 15100533
Estimated Expiration: ⤷  Sign Up

Patent: 16118396
Estimated Expiration: ⤷  Sign Up

Patent: 16136666
Estimated Expiration: ⤷  Sign Up

Patent: 19115913
Estimated Expiration: ⤷  Sign Up

Patent: 19139675
Estimated Expiration: ⤷  Sign Up

Patent: 19142696
Estimated Expiration: ⤷  Sign Up

Patent: 20140867
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 297
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1500212
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2163369
Estimated Expiration: ⤷  Sign Up

Patent: 2177782
Estimated Expiration: ⤷  Sign Up

Patent: 2335160
Estimated Expiration: ⤷  Sign Up

Patent: 2488424
Estimated Expiration: ⤷  Sign Up

Patent: 150028302
Estimated Expiration: ⤷  Sign Up

Patent: 150032560
Estimated Expiration: ⤷  Sign Up

Patent: 160062097
Estimated Expiration: ⤷  Sign Up

Patent: 160137597
Estimated Expiration: ⤷  Sign Up

Patent: 180100567
Estimated Expiration: ⤷  Sign Up

Patent: 200013771
Estimated Expiration: ⤷  Sign Up

Patent: 200018383
Estimated Expiration: ⤷  Sign Up

Patent: 200128214
Estimated Expiration: ⤷  Sign Up

Patent: 210107915
Estimated Expiration: ⤷  Sign Up

Patent: 210148435
Estimated Expiration: ⤷  Sign Up

Patent: 220080205
Estimated Expiration: ⤷  Sign Up

Patent: 230021170
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 69250
Estimated Expiration: ⤷  Sign Up

Patent: 85523
Estimated Expiration: ⤷  Sign Up

Patent: 67709
Estimated Expiration: ⤷  Sign Up

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
Australia 2017208300 Soluble Estradiol Capsule For Vaginal Insertion ⤷  Sign Up
Serbia 62297 PRIRODNE KOMBINOVANE HORMONSKE SUPSTITUCIONE FORMULACIJE I TERAPIJE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Subscribe to access the full database, or Sign Up

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
2782584 21C1058 France ⤷  Sign Up PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
2782584 LUC00245 Luxembourg ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Subscribe to access the full database, or Sign Up

Make Better Decisions: Try a trial or see plans & pricing

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.

 
© Copyright 2002-2024 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
 NCE-1 Patent Challenge Dates 2024 - 2025
 Trigger-based marketing for the life sciences
 Get DrugPatentWatch Business Intelligence Reports at Amazon.com
 DrugChatter - AI-based answers to questions about drugs
 RxJam - Digital Marketing for Life Sciences
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links

Follow DrugPatentWatch:

  DrugPatentWatch Linkedin Group