ESTRACE Drug Patent Profile
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When do Estrace patents expire, and what generic alternatives are available?
Estrace is a drug marketed by Allergan and Bristol Myers Squibb and is included in four NDAs.
The generic ingredient in ESTRACE is estradiol. There are seventy-five drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the estradiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Estrace
A generic version of ESTRACE was approved as estradiol by BARR LABS INC on October 22nd, 1997.
Summary for ESTRACE
Recent Clinical Trials for ESTRACE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dartmouth-Hitchcock Medical Center | Phase 1 |
Gary Schwartz | Phase 1 |
Dartmouth-Hitchcock Medical Center | Phase 2 |
Pharmacology for ESTRACE
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ESTRACE
US Patents and Regulatory Information for ESTRACE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | ESTRACE | estradiol | CREAM;VAGINAL | 086069-001 | Jan 31, 1984 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bristol Myers Squibb | ESTRACE | estradiol | TABLET;ORAL | 084500-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol Myers Squibb | ESTRACE | estradiol | TABLET;ORAL | 081295-001 | Jun 30, 1993 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol Myers Squibb | ESTRACE | estradiol | TABLET;ORAL | 084499-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 ESTRACE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | ESTRACE | estradiol | CREAM;VAGINAL | 086069-001 | Jan 31, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |