ESTRADIOL ACETATE - Generic Drug Details
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What are the generic drug sources for estradiol acetate and what is the scope of freedom to operate?
Estradiol acetate
is the generic ingredient in two branded drugs marketed by Millicent Mfg Pr and Apil, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for ESTRADIOL ACETATE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 127 |
| What excipients (inactive ingredients) are in ESTRADIOL ACETATE? | ESTRADIOL ACETATE excipients list |
| DailyMed Link: | ESTRADIOL ACETATE at DailyMed |
Recent Clinical Trials for ESTRADIOL ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Trust Fertility Clinic | PHASE4 |
| Fudan University | PHASE2 |
| Cairo University | PHASE3 |
Pharmacology for ESTRADIOL ACETATE
| Drug Class | Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL ACETATE
US Patents and Regulatory Information for ESTRADIOL ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Millicent Mfg Pr | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-002 | Mar 20, 2003 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Millicent Mfg Pr | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-001 | Mar 20, 2003 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ 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 ESTRADIOL ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Millicent Mfg Pr | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-001 | Mar 20, 2003 | 5,855,906 | ⤷ Start Trial |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | 7,799,771 | ⤷ Start Trial |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | 6,962,908 | ⤷ Start Trial |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | 7,572,779 | ⤷ Start Trial |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | 7,572,779 | ⤷ Start Trial |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | 6,962,908 | ⤷ Start Trial |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | 7,799,771 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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