ESTRACE Drug Patent Profile
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When do Estrace patents expire, and when can generic versions of Estrace launch?
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-nine 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ESTRACE?
- What are the global sales for ESTRACE?
- What is Average Wholesale Price for ESTRACE?
Summary for ESTRACE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 39 |
| Patent Applications: | 4,063 |
| Drug Prices: | Drug price information for ESTRACE |
| Drug Sales Revenues: | Drug sales revenues for ESTRACE |
| DailyMed Link: | ESTRACE at DailyMed |
Recent Clinical Trials for ESTRACE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Breast Cancer Research Foundation | Phase 2 |
| University of Washington | Phase 2 |
| Gary Schwartz | Phase 1 |
Pharmacology for ESTRACE
| Drug Class | Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bristol Myers Squibb | ESTRACE | estradiol | TABLET;ORAL | 084500-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | ESTRACE | estradiol | TABLET;ORAL | 081295-001 | Jun 30, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | ESTRACE | estradiol | TABLET;ORAL | 084499-001 | Approved Prior to Jan 1, 1982 | 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 |
