Estradiol hemihydrate - Generic Drug Details
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What are the generic drug sources for estradiol hemihydrate and what is the scope of patent protection?
Estradiol hemihydrate
is the generic ingredient in one branded drug marketed by Exeltis Usa Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for estradiol hemihydrate.
Summary for estradiol hemihydrate
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 4 |
| Patent Applications: | 7,013 |
| DailyMed Link: | estradiol hemihydrate at DailyMed |
Recent Clinical Trials for estradiol hemihydrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jim Pattison Children's Hospital Foundation | Phase 1 |
| University of Saskatchewan | Phase 1 |
| Mahidol University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for estradiol hemihydrate
US Patents and Regulatory Information for estradiol hemihydrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exeltis Usa Inc | ESTRASORB | estradiol hemihydrate | EMULSION;TOPICAL | 021371-001 | Oct 9, 2003 | DISCN | 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 |
Expired US Patents for estradiol hemihydrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Exeltis Usa Inc | ESTRASORB | estradiol hemihydrate | EMULSION;TOPICAL | 021371-001 | Oct 9, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
