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ENJUVIA Drug Profile
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» See Plans and PricingWhen do Enjuvia patents expire, and when can generic versions of Enjuvia launch?
Enjuvia is a drug marketed by Aspen and is included in one NDA. There are two patents protecting this drug.
This drug has seventeen patent family members in nine countries.
The generic ingredient in ENJUVIA is estrogens, conjugated synthetic b. There are three drug master file entries for this compound. Additional details are available on the estrogens, conjugated synthetic b profile page.
US ANDA Litigation and Generic Entry Outlook for Enjuvia
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 8, 2021. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ENJUVIA
| International Patents: | 17 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ENJUVIA at DailyMed |
Generic Entry Opportunity Date for ENJUVIA
Generic Entry Date for ENJUVIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.
Recent Clinical Trials for ENJUVIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duramed Research | Phase 4 |
| Duramed Research | Phase 3 |
US Patents and Regulatory Information for ENJUVIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-001 | Dec 20, 2004 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-002 | Dec 20, 2004 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-004 | May 10, 2004 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-001 | Dec 20, 2004 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-002 | Dec 20, 2004 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-005 | Apr 27, 2007 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-005 | Apr 27, 2007 | DISCN | No | No | Start Trial | Start Trial | Y | 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 |
Premature patent expiration for: ENJUVIA
Expiration due to failure to pay maintenance fee
| Patent Number | Tradename | Expiration Date |
|---|---|---|
| Start Trial | ENJUVIA | Start Trial |
International Patents for ENJUVIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2004500396 | Start Trial |
| Mexico | PA02008856 | Start Trial |
| Australia | 4541701 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0168669 | Start Trial |
| Austria | 377605 | Start Trial |
| Japan | 2011256181 | Start Trial |
| Australia | 2001245417 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
