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
Summary for BIJUVA
International Patents: | 148 |
US Patents: | 21 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
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 |


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.
Anatomical Therapeutic Chemical (ATC) Classes for BIJUVA
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 |