DrugPatentWatch Database Preview
BIJUVA Drug Profile
When do Bijuva patents expire, and what generic alternatives are available?
Bijuva is a drug marketed by Therapeuticsmd Inc and is included in one NDA. There are twelve patents protecting this drug.
This drug has one hundred and seven patent family members in twelve 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.
Summary for BIJUVA
| International Patents: | 107 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | BIJUVA at DailyMed |
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.
US Patents and Regulatory Information for BIJUVA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Therapeuticsmd Inc | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Therapeuticsmd Inc | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Therapeuticsmd Inc | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Therapeuticsmd Inc | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2015264003 | Start Trial |
| Russian Federation | 2016136666 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2015073177 | Start Trial |
| Mexico | 2014015900 | Start Trial |
| Mexico | 2016011706 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BIJUVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 15C0050 | France | Start Trial | 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 | C300221 | Netherlands | Start Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1453521 | 122015000093 | Germany | Start Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 1380301 | 2009C/007 | Belgium | Start Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
