ESTRADIOL VALERATE - Generic Drug Details
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What are the generic drug sources for estradiol valerate and what is the scope of patent protection?
Estradiol valerate
is the generic ingredient in four branded drugs marketed by Endo Operations, Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, Xiromed, and Savage Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for estradiol valerate. Four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ESTRADIOL VALERATE
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 8 |
NDAs: | 11 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 67 |
Patent Applications: | 4,722 |
Drug Prices: | Drug price trends for ESTRADIOL VALERATE |
What excipients (inactive ingredients) are in ESTRADIOL VALERATE? | ESTRADIOL VALERATE excipients list |
DailyMed Link: | ESTRADIOL VALERATE at DailyMed |
Recent Clinical Trials for ESTRADIOL VALERATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ART Fertility Clinics LLC | Phase 1 |
El Shatby University Hospital for Obstetrics and Gynecology | Phase 2/Phase 3 |
University of California, San Diego | Phase 4 |
Generic filers with tentative approvals for ESTRADIOL VALERATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 3MG;2MG;3MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 1MG;2MG;2MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 203723-001 | Apr 21, 2020 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Xiromed | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 216656-003 | Apr 28, 2023 | AO | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Savage Labs | DITATE-DS | estradiol valerate; testosterone enanthate | INJECTABLE;INJECTION | 086423-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Am Regent | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 090920-001 | Jan 19, 2010 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Xiromed | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 216656-002 | Apr 28, 2023 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 203723-003 | Apr 21, 2020 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fosun Pharma | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 040628-002 | Oct 4, 2007 | DISCN | No | 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 |
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