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Estrogens, conjugated synthetic b - Generic Drug Details
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What are the generic sources for estrogens, conjugated synthetic b and what is the scope of freedom to operate?
Estrogens, conjugated synthetic b
is the generic ingredient in one branded drug marketed by Aspen and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Estrogens, conjugated synthetic b has seventeen patent family members in nine countries.
There are three drug master file entries for estrogens, conjugated synthetic b.
Summary for estrogens, conjugated synthetic b
| International Patents: | 17 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Clinical Trials: | 6 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | estrogens, conjugated synthetic b at DailyMed |
Recent Clinical Trials for estrogens, conjugated synthetic b
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duramed Research | Phase 4 |
| The Alfred | Phase 2 |
| Stanley Medical Research Institute | Phase 2 |
US Patents and Regulatory Information for estrogens, conjugated synthetic b
| 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 | 021443-003 | May 10, 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 | ||
| 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 | 021443-004 | May 10, 2004 | 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 |
Expired US Patents for estrogens, conjugated synthetic b
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-001 | Dec 20, 2004 | Start Trial | Start Trial |
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-005 | Apr 27, 2007 | Start Trial | Start Trial |
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-003 | May 10, 2004 | Start Trial | Start Trial |
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-004 | May 10, 2004 | Start Trial | Start Trial |
| Aspen | ENJUVIA | estrogens, conjugated synthetic b | TABLET;ORAL | 021443-002 | Dec 20, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for estrogens, conjugated synthetic b
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2001245417 | Start Trial |
| Japan | 2004500396 | Start Trial |
| European Patent Office | 1267852 | Start Trial |
| Japan | 2011256181 | Start Trial |
| Canada | 2402667 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
