ESTRADIOL VALERATE Drug Patent Profile
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When do Estradiol Valerate patents expire, and when can generic versions of Estradiol Valerate launch?
Estradiol Valerate is a drug marketed by Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, and Xiromed. and is included in seven NDAs.
The generic ingredient in ESTRADIOL VALERATE is estradiol valerate. There are seventy-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Estradiol Valerate
A generic version of ESTRADIOL VALERATE was approved as estradiol valerate by AM REGENT on January 19th, 2010.
Summary for ESTRADIOL VALERATE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 66 |
| Patent Applications: | 3,110 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ESTRADIOL VALERATE |
| DailyMed Link: | ESTRADIOL VALERATE at DailyMed |
Recent Clinical Trials for ESTRADIOL VALERATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| El Shatby University Hospital for Obstetrics and Gynecology | Phase 2/Phase 3 |
| University of California, San Diego | Phase 4 |
| Sohag University | Early Phase 1 |
Pharmacology for ESTRADIOL VALERATE
| Drug Class | Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL VALERATE
US Patents and Regulatory Information for ESTRADIOL VALERATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 090920-001 | Jan 19, 2010 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fosun Pharma | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 040628-003 | Oct 4, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dr Reddys | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 083714-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Xiromed | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 216656-001 | Apr 28, 2023 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 203723-001 | Apr 21, 2020 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Xiromed | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 216656-003 | Apr 28, 2023 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Am Regent | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 090920-002 | Jan 19, 2010 | AO | RX | No | 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 |
