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Last Updated: May 26, 2022

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 Therapeuticsmd Inc and is included in one NDA. There are twenty-one patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-eight patent family members in nineteen countries.

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

DrugPatentWatch® Generic Entry Outlook for Bijuva

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 21, 2032. This may change due to patent challenges or generic licensing.

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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Drug patent expirations by year for BIJUVA
Drug Prices for BIJUVA

See drug prices for BIJUVA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BIJUVA
Generic Entry Date for BIJUVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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-one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BIJUVA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting BIJUVA

Progesterone formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Progesterone formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Progesterone formulations having a desirable pk profile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Natural combination hormone replacement formulations and therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Patent: 8160
Estimated Expiration: See Plans and Pricing

Patent: 9872
Estimated Expiration: See Plans and Pricing

Patent: 7022
Estimated Expiration: See Plans and Pricing

Australia

Patent: 6507
Estimated Expiration: See Plans and Pricing

Patent: 12340589
Estimated Expiration: See Plans and Pricing

Patent: 13211876
Estimated Expiration: See Plans and Pricing

Patent: 13277233
Estimated Expiration: See Plans and Pricing

Patent: 13277234
Estimated Expiration: See Plans and Pricing

Patent: 13277235
Estimated Expiration: See Plans and Pricing

Patent: 13277236
Estimated Expiration: See Plans and Pricing

Patent: 14349132
Estimated Expiration: See Plans and Pricing

Patent: 15237243
Estimated Expiration: See Plans and Pricing

Patent: 16366200
Estimated Expiration: See Plans and Pricing

Patent: 17206262
Estimated Expiration: See Plans and Pricing

Patent: 17208300
Estimated Expiration: See Plans and Pricing

Patent: 18222947
Estimated Expiration: See Plans and Pricing

Patent: 18280270
Estimated Expiration: See Plans and Pricing

Patent: 19204653
Estimated Expiration: See Plans and Pricing

Patent: 19204655
Estimated Expiration: See Plans and Pricing

Patent: 19204658
Estimated Expiration: See Plans and Pricing

Patent: 21218231
Estimated Expiration: See Plans and Pricing

Patent: 21240253
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014012444
Estimated Expiration: See Plans and Pricing

Patent: 2014031824
Estimated Expiration: See Plans and Pricing

Patent: 2014031837
Estimated Expiration: See Plans and Pricing

Patent: 2014031910
Estimated Expiration: See Plans and Pricing

Patent: 2014031914
Estimated Expiration: See Plans and Pricing

Patent: 2018011483
Estimated Expiration: See Plans and Pricing

Patent: 2019025914
Estimated Expiration: See Plans and Pricing

Canada

Patent: 6044
Estimated Expiration: See Plans and Pricing

Patent: 56520
Estimated Expiration: See Plans and Pricing

Patent: 61346
Estimated Expiration: See Plans and Pricing

Patent: 76947
Estimated Expiration: See Plans and Pricing

Patent: 76964
Estimated Expiration: See Plans and Pricing

Patent: 76968
Estimated Expiration: See Plans and Pricing

Patent: 76977
Estimated Expiration: See Plans and Pricing

Patent: 26342
Estimated Expiration: See Plans and Pricing

Patent: 42568
Estimated Expiration: See Plans and Pricing

Patent: 07636
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0210861
Estimated Expiration: See Plans and Pricing

Patent: 0211377
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 82584
Estimated Expiration: See Plans and Pricing

Patent: 06742
Estimated Expiration: See Plans and Pricing

Patent: 61072
Estimated Expiration: See Plans and Pricing

Patent: 61073
Estimated Expiration: See Plans and Pricing

Patent: 61233
Estimated Expiration: See Plans and Pricing

Patent: 61234
Estimated Expiration: See Plans and Pricing

Patent: 60179
Estimated Expiration: See Plans and Pricing

Patent: 22364
Estimated Expiration: See Plans and Pricing

Patent: 86514
Estimated Expiration: See Plans and Pricing

Patent: 60500
Estimated Expiration: See Plans and Pricing

Patent: 09586
Estimated Expiration: See Plans and Pricing

Patent: 36133
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 55275
Estimated Expiration: See Plans and Pricing

Patent: 55562
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6358
Estimated Expiration: See Plans and Pricing

Patent: 6359
Estimated Expiration: See Plans and Pricing

Patent: 5139
Estimated Expiration: See Plans and Pricing

Patent: 7828
Estimated Expiration: See Plans and Pricing

Patent: 9884
Estimated Expiration: See Plans and Pricing

Japan

Patent: 24393
Estimated Expiration: See Plans and Pricing

Patent: 85866
Estimated Expiration: See Plans and Pricing

Patent: 98460
Estimated Expiration: See Plans and Pricing

Patent: 34519
Estimated Expiration: See Plans and Pricing

Patent: 42334
Estimated Expiration: See Plans and Pricing

Patent: 42389
Estimated Expiration: See Plans and Pricing

Patent: 97402
Estimated Expiration: See Plans and Pricing

Patent: 56215
Estimated Expiration: See Plans and Pricing

Patent: 80672
Estimated Expiration: See Plans and Pricing

Patent: 82127
Estimated Expiration: See Plans and Pricing

Patent: 15504924
Estimated Expiration: See Plans and Pricing

Patent: 15507607
Estimated Expiration: See Plans and Pricing

Patent: 15519405
Estimated Expiration: See Plans and Pricing

Patent: 15520235
Estimated Expiration: See Plans and Pricing

Patent: 15520236
Estimated Expiration: See Plans and Pricing

Patent: 15520237
Estimated Expiration: See Plans and Pricing

Patent: 16534025
Estimated Expiration: See Plans and Pricing

Patent: 17509630
Estimated Expiration: See Plans and Pricing

Patent: 18024685
Estimated Expiration: See Plans and Pricing

Patent: 18024688
Estimated Expiration: See Plans and Pricing

Patent: 18199711
Estimated Expiration: See Plans and Pricing

Patent: 18538290
Estimated Expiration: See Plans and Pricing

Patent: 19206540
Estimated Expiration: See Plans and Pricing

Patent: 19214598
Estimated Expiration: See Plans and Pricing

Patent: 20100642
Estimated Expiration: See Plans and Pricing

Patent: 21119155
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 82584
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 8435
Estimated Expiration: See Plans and Pricing

Patent: 5818
Estimated Expiration: See Plans and Pricing

Patent: 7596
Estimated Expiration: See Plans and Pricing

Patent: 14006256
Estimated Expiration: See Plans and Pricing

Patent: 14009093
Estimated Expiration: See Plans and Pricing

Patent: 14015897
Estimated Expiration: See Plans and Pricing

Patent: 14015898
Estimated Expiration: See Plans and Pricing

Patent: 14015899
Estimated Expiration: See Plans and Pricing

Patent: 14015900
Estimated Expiration: See Plans and Pricing

Patent: 16005092
Estimated Expiration: See Plans and Pricing

Patent: 16011706
Estimated Expiration: See Plans and Pricing

Patent: 18006882
Estimated Expiration: See Plans and Pricing

Poland

Patent: 82584
Estimated Expiration: See Plans and Pricing

Patent: 61073
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 82584
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 13888
Estimated Expiration: See Plans and Pricing

Patent: 40059
Estimated Expiration: See Plans and Pricing

Patent: 15100531
Estimated Expiration: See Plans and Pricing

Patent: 15100533
Estimated Expiration: See Plans and Pricing

Patent: 16118396
Estimated Expiration: See Plans and Pricing

Patent: 16136666
Estimated Expiration: See Plans and Pricing

Patent: 19139675
Estimated Expiration: See Plans and Pricing

Patent: 19142696
Estimated Expiration: See Plans and Pricing

Patent: 20140867
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 297
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1500212
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2163369
Estimated Expiration: See Plans and Pricing

Patent: 2177782
Estimated Expiration: See Plans and Pricing

Patent: 2335160
Estimated Expiration: See Plans and Pricing

Patent: 150028302
Estimated Expiration: See Plans and Pricing

Patent: 150032560
Estimated Expiration: See Plans and Pricing

Patent: 160062097
Estimated Expiration: See Plans and Pricing

Patent: 160137597
Estimated Expiration: See Plans and Pricing

Patent: 180100567
Estimated Expiration: See Plans and Pricing

Patent: 200013771
Estimated Expiration: See Plans and Pricing

Patent: 200128214
Estimated Expiration: See Plans and Pricing

Patent: 210107915
Estimated Expiration: See Plans and Pricing

Patent: 210148435
Estimated Expiration: See Plans and Pricing

Spain

Patent: 69250
Estimated Expiration: See Plans and Pricing

Patent: 85523
Estimated Expiration: See Plans and Pricing

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 2019204655 Natural Combination Hormone Replacement Formulations And Therapies See Plans and Pricing
Israel 248985 See Plans and Pricing
Australia 2015237243 Progesterone formulations See Plans and Pricing
Argentina 107022 COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS POR VÍA VAGINAL Y MÉTODOS See Plans and Pricing
Australia 2017208300 Soluble Estradiol Capsule For Vaginal Insertion See Plans and Pricing
Portugal 2782584 See Plans and Pricing
Mexico 2014015898 FORMULACIONES Y TERAPIAS DE REEMPLAZO DE COMBINACION DE HORMONAS NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.) See Plans and Pricing
>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 See Plans and Pricing 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
1453521 122015000093 Germany See Plans and Pricing PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
2782584 LUC00245 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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 15C0050 France See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0398460 12/2004 Austria See Plans and Pricing PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1453521 C201630040 Spain See Plans and Pricing PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKesson
Medtronic

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.