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BIJUVA Drug Profile
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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 eleven 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.
US ANDA Litigation and Generic Entry Outlook for Bijuva
Bijuva was eligible for patent challenges on December 31, 1968.
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.
Indicators of Generic Entry
Summary for BIJUVA
| International Patents: | 111 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BIJUVA |
| 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.
Pharmacology for BIJUVA
| Drug Class | Estrogen Progesterone |
| Mechanism of Action | Estrogen Receptor Agonists |
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 | |||
| >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 |
|---|---|---|
| Canada | 166044 | Start Trial |
| South Korea | 20170005819 | Start Trial |
| Japan | 2015507607 | Start Trial |
| Israel | 247828 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BIJUVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0334429 | 97C0002 | Belgium | Start Trial | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
| 1453521 | CA 2016 00016 | Denmark | Start Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
