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 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: | 171 |
| US Patents: | 24 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| 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 |
Pharmacology for BIJUVA
| Drug Class | Estrogen Progesterone |
| Mechanism of Action | Estrogen Receptor Agonists |
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-four US patents.
Patents protecting BIJUVA
Progesterone formulations
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Natural combination hormone replacement formulations and therapies
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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Progesterone formulations
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Natural combination hormone replacement formulations and therapies
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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Natural combination hormone replacement formulations and therapies
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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
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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Natural combination hormone replacement formulations and therapies
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Natural combination hormone replacement formulations and therapies
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Natural combination hormone replacement formulations and therapies
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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
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Natural combination hormone replacement formulations and therapies
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Natural combination hormone replacement formulations and therapies
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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Natural combination hormone replacement formulations and therapies
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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Natural combination hormone replacement formulations and therapies
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Patented Use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Natural combination hormone replacement formulations and therapies
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Natural combination hormone replacement formulations and therapies
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Natural combination hormone replacement formulations and therapies
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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
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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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 | ||||
| >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: ⤷ Sign Up
Patent: 8160
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Patent: 9872
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Patent: 7022
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Australia
Patent: 6507
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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: 61073
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Portugal
Patent: 82584
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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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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 |
| Portugal | 2782584 | ⤷ Sign Up | |
| South Korea | 20150028302 | NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES | ⤷ Sign Up |
| Canada | 2942568 | FORMULATIONS DE PROGESTERONE (PROGESTERONE FORMULATIONS) | ⤷ Sign Up |
| Croatia | P20211377 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BIJUVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | C201630040 | Spain | ⤷ Sign Up | 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 |
| 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 |
| 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 | 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 | 132021000000197 | Italy | ⤷ Sign Up | 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 |
| >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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