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Last Updated: November 2, 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
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
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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
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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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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
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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

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

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
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

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
Patent: FORMULACIÓN Y TERAPIAS PARA SUSTITUCIÓN HORMONAL DE COMBINACIÓN NATURAL
Estimated Expiration: ⤷  Sign Up

Patent: 8160
Patent: COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS
Estimated Expiration: ⤷  Sign Up

Patent: 9872
Patent: FORMULACIONES DE PROGESTERONA
Estimated Expiration: ⤷  Sign Up

Patent: 7022
Patent: COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS POR VÍA VAGINAL Y MÉTODOS
Estimated Expiration: ⤷  Sign Up

Patent: 7914
Patent: COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 6507
Estimated Expiration: ⤷  Sign Up

Patent: 12340589
Patent: Natural combination hormone replacement formulations and therapies
Estimated Expiration: ⤷  Sign Up

Patent: 13211876
Patent: Transdermal hormone replacement therapies
Estimated Expiration: ⤷  Sign Up

Patent: 13277233
Patent: Progesterone formulations
Estimated Expiration: ⤷  Sign Up

Patent: 13277234
Patent: Soluble estradiol capsule for vaginal insertion
Estimated Expiration: ⤷  Sign Up

Patent: 13277235
Patent: Transdermal hormone replacement therapies
Estimated Expiration: ⤷  Sign Up

Patent: 13277236
Patent: Natural combination hormone replacement formulations and therapies
Estimated Expiration: ⤷  Sign Up

Patent: 14349132
Patent: Vaginal inserted estradiol pharmaceutical compositons and methods
Estimated Expiration: ⤷  Sign Up

Patent: 15237243
Patent: Progesterone formulations
Estimated Expiration: ⤷  Sign Up

Patent: 16366200
Patent: Vaginal inserted estradiol pharmaceutical compositions and methods
Estimated Expiration: ⤷  Sign Up

Patent: 17206262
Patent: Natural Combination Hormone Replacement Formulations And Therapies
Estimated Expiration: ⤷  Sign Up

Patent: 17208300
Patent: Soluble Estradiol Capsule For Vaginal Insertion
Estimated Expiration: ⤷  Sign Up

Patent: 17394679
Patent: Natural combination hormone replacement formulations and therapies
Estimated Expiration: ⤷  Sign Up

Patent: 18222947
Patent: Progesterone Formulations
Estimated Expiration: ⤷  Sign Up

Patent: 18280270
Patent: Vaginal inserted estradiol pharmaceutical compositions and methods
Estimated Expiration: ⤷  Sign Up

Patent: 19204653
Patent: Soluble Estradiol Capsule For Vaginal Insertion
Estimated Expiration: ⤷  Sign Up

Patent: 19204655
Patent: Natural Combination Hormone Replacement Formulations And Therapies
Estimated Expiration: ⤷  Sign Up

Patent: 19204658
Patent: Vaginal Inserted Estradiol Pharmaceutical Compositions And Methods
Estimated Expiration: ⤷  Sign Up

Patent: 21218231
Patent: Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods
Estimated Expiration: ⤷  Sign Up

Patent: 21240253
Patent: Natural Combination Hormone Replacement Formulations And Therapies
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014012444
Patent: formulações e terapias de reposição hormonal natural combinada
Estimated Expiration: ⤷  Sign Up

Patent: 2014018439
Estimated Expiration: ⤷  Sign Up

Patent: 2014031824
Patent: terapias de reposição hormonal transdérmica
Estimated Expiration: ⤷  Sign Up

Patent: 2014031837
Patent: formulações de progesterona
Estimated Expiration: ⤷  Sign Up

Patent: 2014031910
Patent: formulações e terapias naturais de combinação para reposição hormonal
Estimated Expiration: ⤷  Sign Up

Patent: 2014031914
Patent: cápsula de estradiol solúvel para inserção vaginal
Estimated Expiration: ⤷  Sign Up

Patent: 2016009008
Estimated Expiration: ⤷  Sign Up

Patent: 2018011483
Patent: métodos e composições farmacêuticas com estradiol vaginalmente inserido
Estimated Expiration: ⤷  Sign Up

Patent: 2019011655
Patent: fórmulas e terapias naturais combinadas para reposição
Estimated Expiration: ⤷  Sign Up

Patent: 2019025914
Patent: composições farmacêuticas de estradiol para inserção vaginal e métodos
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Canada

Patent: 6044
Estimated Expiration: ⤷  Sign Up

Patent: 56520
Patent: PREPARATIONS ET THERAPIES DE SUBSTITUTION POUR HORMONOTHERAPIE NATURELLE COMBINEE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 61346
Patent: THERAPIES TRANSDERMIQUES DE REMPLACEMENT D'HORMONE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 76947
Patent: TRAITEMENT TRANSDERMIQUE DE SUBSTITUTION HORMONALE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 76964
Patent: FORMULATIONS DE PROGESTERONE (PROGESTERONE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 76968
Patent: CAPSULE D'ESTRADIOL SOLUBLE POUR INSERTION VAGINALE (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION)
Estimated Expiration: ⤷  Sign Up

Patent: 76977
Patent: FORMULATIONS ET THERAPIES DE REMPLACEMENT D'HORMONES DE COMBINAISON NATURELLE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 26342
Patent: COMPOSITIONS PHARMACEUTIQUES A BASE D'ESTRADIOL POUR INSERTION VAGINALE ET METHODES ASSOCIEES (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Patent: 42568
Patent: FORMULATIONS DE PROGESTERONE (PROGESTERONE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 07636
Patent: COMPOSITIONS PHARMACEUTIQUES A BASE D'OESTRADIOL INTRODUITES PAR VOIE VAGINALE ET PROCEDES ASSOCIES (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Patent: 45024
Patent: THERAPIES ET FORMULATIONS HORMONALES DE SUBSTITUTION COMBINATOIRES NATURELLES (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

China

Patent: 0290793
Patent: 天然组合激素替代制剂和治疗 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0210861
Estimated Expiration: ⤷  Sign Up

Patent: 0211377
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 82584
Patent: PRÉPARATIONS ET THÉRAPIES DE SUBSTITUTION POUR HORMONOTHÉRAPIE NATURELLE COMBINÉE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 06742
Patent: THÉRAPIES TRANSDERMIQUES DE REMPLACEMENT D'HORMONE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 61072
Patent: FORMULATIONS ET THÉRAPIES DE REMPLACEMENT D'HORMONES DE COMBINAISON NATURELLE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 61073
Patent: CAPSULE D'ESTRADIOL SOLUBLE POUR INSERTION VAGINALE (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION)
Estimated Expiration: ⤷  Sign Up

Patent: 61233
Patent: TRAITEMENT TRANSDERMIQUE DE SUBSTITUTION HORMONALE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 61234
Patent: FORMULATIONS DE PROGESTÉRONE (PROGESTERONE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 60179
Patent: COMPOSITIONS PHARMACEUTIQUES À BASE D'ESTRADIOL POUR INSERTION VAGINALE ET MÉTHODES ASSOCIÉES (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Patent: 22364
Patent: FORMULATIONS DE PROGESTÉRONE (PROGESTERONE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 86514
Patent: COMPOSITIONS PHARMACEUTIQUES À BASE D' STRADIOL INTRODUITES PAR VOIE VAGINALE ET PROCÉDÉS ASSOCIÉS (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Patent: 48036
Patent: THÉRAPIES ET FORMULATIONS HORMONALES DE SUBSTITUTION COMBINATOIRES NATURELLES (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 60500
Patent: FORMULATIONS DE PROGESTÉRONE (PROGESTERONE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 09586
Patent: CAPSULE D' STRADIOL SOLUBLE POUR INSERTION VAGINALE (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION)
Estimated Expiration: ⤷  Sign Up

Patent: 36133
Patent: PRÉPARATIONS ET THÉRAPIES DE SUBSTITUTION POUR HORMONOTHÉRAPIE NATURELLE COMBINÉE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 09646
Patent: FORMULATIONS ET THÉRAPIES DE REMPLACEMENT D'HORMONES COMBINÉES NATURELLES (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
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
Patent: תכשירים תרופתיים המכילים תחליפי הורמונים והשימוש בהם (Pharmaceutical compositions comprising hormone replacement formulations and uses thereof)
Estimated Expiration: ⤷  Sign Up

Patent: 6359
Patent: קפסולת אסטראדיול מסיס להחדרה וגינאלית (Soluble estradiol capsule for vaginal insertion)
Estimated Expiration: ⤷  Sign Up

Patent: 5139
Patent: שיטות והרכבים פרמצבטיים של אסטרדיול להחדרה וגינלית (Vaginal inserted estradiol pharmaceutical compositions and methods)
Estimated Expiration: ⤷  Sign Up

Patent: 9884
Patent: הרכבי אסתרדיול תרופתיים להכנסה וגינלית ושיטות שימוש בהם (Vaginal inserted estradiol pharmaceutical compositions and methods)
Estimated Expiration: ⤷  Sign Up

Patent: 7023
Patent: פורמולציות של תחליף טבעי של שילובי הורמונים וטיפולים בעזרתן (Natural combination hormone replacement formulations and therapies)
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
Patent: 経皮ホルモン補充療法
Estimated Expiration: ⤷  Sign Up

Patent: 15507607
Patent: 天然複合ホルモン補充製剤および療法
Estimated Expiration: ⤷  Sign Up

Patent: 15519405
Patent: 膣内挿入用可溶性エストラジオールカプセル
Estimated Expiration: ⤷  Sign Up

Patent: 15520235
Patent: プロゲステロン製剤
Estimated Expiration: ⤷  Sign Up

Patent: 15520236
Patent: 経皮的ホルモン補充療法
Estimated Expiration: ⤷  Sign Up

Patent: 15520237
Patent: 天然の併用ホルモン補充療法剤及び治療
Estimated Expiration: ⤷  Sign Up

Patent: 16534025
Patent: 膣挿入されるエストラジオール薬学的組成物及び方法
Estimated Expiration: ⤷  Sign Up

Patent: 17509630
Patent: プロゲステロン製剤
Estimated Expiration: ⤷  Sign Up

Patent: 18024685
Patent: 天然複合ホルモン補充製剤および療法 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 18024688
Patent: 天然の併用ホルモン補充療法剤及び治療 (NATURAL COMBINATION HORMONE REPLACEMENT THERAPY AGENTS AND THERAPIES)
Estimated Expiration: ⤷  Sign Up

Patent: 18199711
Patent: 膣内挿入用可溶性エストラジオールカプセル (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION)
Estimated Expiration: ⤷  Sign Up

Patent: 18538290
Patent: 膣挿入エストラジオール医薬組成物および方法
Estimated Expiration: ⤷  Sign Up

Patent: 19206540
Patent: プロゲステロン製剤 (PROGESTERONE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 19214598
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 20100642
Patent: 膣内挿入用可溶性エストラジオールカプセル (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION)
Estimated Expiration: ⤷  Sign Up

Patent: 20504093
Patent: 天然配合ホルモン補充製剤及び治療法
Estimated Expiration: ⤷  Sign Up

Patent: 21119155
Patent: 膣挿入エストラジオール医薬組成物および方法 (VAGINAL INSERTION ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 82584
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 8435
Patent: CAPSULA DE ESTRADIOL SOLUBLE PARA INSERCION POR VIA VAGINAL. (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION.)
Estimated Expiration: ⤷  Sign Up

Patent: 5818
Patent: FORMULACIONES Y TERAPIAS DE REEMPLAZO HORMONAL DE COMBINACION NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.)
Estimated Expiration: ⤷  Sign Up

Patent: 7596
Patent: TRATAMIENTOS TRANSDERMICOS DE SUSTITUCION HORMONAL. (TRANSDERMAL HORMONE REPLACEMENT THERAPIES.)
Estimated Expiration: ⤷  Sign Up

Patent: 14006256
Patent: FORMULACIONES Y TERAPIAS DE REEMPLAZO HORMONAL DE COMBINACION NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.)
Estimated Expiration: ⤷  Sign Up

Patent: 14009093
Patent: TRATAMIENTOS TRANSDERMICOS DE SUSTITUCION HORMONAL. (TRANSDERMAL HORMONE REPLACEMENT THERAPIES.)
Estimated Expiration: ⤷  Sign Up

Patent: 14015897
Patent: TERAPIAS DE REEMPLAZO HORMONAL TRANSDERMICAS. (TRANSDERMAL HORMONE REPLACEMENT THERAPIES.)
Estimated Expiration: ⤷  Sign Up

Patent: 14015898
Patent: FORMULACIONES Y TERAPIAS DE REEMPLAZO DE COMBINACION DE HORMONAS NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.)
Estimated Expiration: ⤷  Sign Up

Patent: 14015899
Patent: CAPSULA DE ESTRADIOL SOLUBLE PARA INSERCION POR VIA VAGINAL. (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION.)
Estimated Expiration: ⤷  Sign Up

Patent: 14015900
Patent: FORMULACIONES DE PROGESTERONA. (PROGESTERONE FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Patent: 16005092
Patent: COMPOSICIONES FARMACEUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y METODOS. (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS.)
Estimated Expiration: ⤷  Sign Up

Patent: 16011706
Patent: FORMULACIONES DE PROGESTERONA. (PROGESTERONE FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Patent: 18006882
Patent: COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS POR VÍA VAGINAL Y MÉTODOS. (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷  Sign Up

Patent: 19006513
Patent: FORMULACIONES Y TERAPIAS DE REEMPLAZO DE HORMONAS DE COMBINACION NATURAL. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.)
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Patent: 20013533
Patent: FORMULACIONES Y TERAPIAS DE REEMPLAZO DE COMBINACION DE HORMONAS NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.)
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Patent: 22002614
Patent: EL USO DE UN PESARIO QUE COMPRENDE UNA CAPSULA QUE CONTIENE ESTRADIOL Y UN AGENTE SOLUBILIZANTE PARA EL TRATAMIENTO DE LA ATROFIA VULVOVAGINAL. (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS.)
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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
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ И СПОСОБЫ НА ОСНОВЕ ЭСТРАДИОЛА ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ (PHARMACEUTICAL COMPOSITIONS AND METHODS BASED ON OESTRADIOL FOR INTRAVAGINAL INTRODUCTION)
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Patent: 40059
Patent: КАПСУЛЫ С РАСТВОРИМЫМ ЭСТРАДИОЛОМ ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ (CAPSULES WITH SOLUBLE OESTRADIOL FOR INTRAVAGINAL INTRODUCTION)
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Patent: 15100531
Patent: КАПСУЛЫ С РАСТВОРИМЫМ ЭСТРАДИОЛОМ ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ
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Patent: 15100533
Patent: ЕСТЕСТВЕННАЯ КОМБИНАЦИЯ СОСТАВОВ И СПОСОБОВ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ
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Patent: 16118396
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ И СПОСОБЫ НА ОСНОВЕ ЭСТРАДИОЛА ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ
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Patent: 16136666
Patent: СОСТАВЫ НА ОСНОВЕ ПРОГЕСТЕРОНА
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Patent: 19115913
Patent: ПРИРОДНЫЕ КОМБИНИРОВАННЫЕ ГОРМОНОЗАМЕСТИТЕЛЬНЫЕ СОСТАВЫ И СПОСОБЫ ТЕРАПИИ
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Patent: 19139675
Patent: ВАГИНАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭСТРАДИОЛ, И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
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Patent: 19142696
Patent: ЕСТЕСТВЕННАЯ КОМБИНАЦИЯ СОСТАВОВ И СПОСОБОВ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ
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Patent: 20140867
Patent: КАПСУЛЫ С РАСТВОРИМЫМ ЭСТРАДИОЛОМ ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ
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Serbia

Patent: 297
Patent: PRIRODNE KOMBINOVANE HORMONSKE SUPSTITUCIONE FORMULACIJE I TERAPIJE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
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South Africa

Patent: 1500212
Patent: PROGESTERONE FORMULATIONS
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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
Patent: NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES
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Patent: 150032560
Patent: SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION
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Patent: 160062097
Patent: 질내 삽입형 에스트라다이올 약제학적 조성물 및 방법 (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS)
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Patent: 160137597
Patent: 프로게스테론 제형 (PROGESTERONE FORMULATIONS)
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Patent: 180100567
Patent: 질 삽입식 에스트라디올 약제학적 조성물 및 방법
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Patent: 200013771
Patent: 질 삽입 에스트라디올 약학적 조성물 및 방법
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Patent: 200018383
Patent: 천연 복합 호르몬 대체 제형 및 요법
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Patent: 200128214
Patent: 천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
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Patent: 210107915
Patent: 천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
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Patent: 210148435
Patent: 질내 삽입형 에스트라다이올 약제학적 조성물 및 방법 (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS)
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Patent: 220080205
Patent: 천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
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Patent: 230021170
Patent: 천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
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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
Serbia 62297 PRIRODNE KOMBINOVANE HORMONSKE SUPSTITUCIONE FORMULACIJE I TERAPIJE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Sign Up
Russian Federation 2019139675 ВАГИНАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭСТРАДИОЛ, И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2013192251 ⤷  Sign Up
Mexico 367596 TRATAMIENTOS TRANSDERMICOS DE SUSTITUCION HORMONAL. (TRANSDERMAL HORMONE REPLACEMENT THERAPIES.) ⤷  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
Japan 2018024685 天然複合ホルモン補充製剤および療法 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Sign Up
European Patent Office 2861073 CAPSULE D'ESTRADIOL SOLUBLE POUR INSERTION VAGINALE (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BIJUVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2782584 301153 Netherlands ⤷  Sign Up PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
2782584 122021000080 Germany ⤷  Sign Up 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
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 15C0050 France ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 C 2015 029 Romania ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
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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