PRASTERONE - Generic Drug Details
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What are the generic drug sources for prasterone and what is the scope of freedom to operate?
Prasterone
is the generic ingredient in one branded drug marketed by Millicent and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Prasterone has fifty-eight patent family members in thirty-one countries.
There are seven drug master file entries for prasterone. One supplier is listed for this compound.
Summary for PRASTERONE
International Patents: | 58 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 17 |
Patent Applications: | 6,792 |
What excipients (inactive ingredients) are in PRASTERONE? | PRASTERONE excipients list |
DailyMed Link: | PRASTERONE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PRASTERONE
Generic Entry Date for PRASTERONE*:
Constraining patent/regulatory exclusivity:
Dosage:
INSERT;VAGINAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for PRASTERONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Lee's Pharmaceutical Limited | Phase 3 |
AMAG Pharmaceuticals, Inc. | Phase 2 |
University of Arkansas | Phase 2 |
US Patents and Regulatory Information for PRASTERONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
EU/EMA Drug Approvals for PRASTERONE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Endoceutics S.A. | Intrarosa | prasterone | EMEA/H/C/004138 Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms., |
Authorised | no | no | no | 2018-01-08 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PRASTERONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Singapore | 183702 | DHEA COMPOSITIONS FOR TREATING MENOPAUSE | ⤷ Try a Trial |
Argentina | 114051 | COMPOSICIONES FARMACÉUTICAS Y SUPOSITORIO VAGINAL | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2009021323 | ⤷ Try a Trial | |
Chile | 2008002362 | Composicion farmaceutica vaginal que comprende menor igual que 13 mg de dehidroepiandrosterona, sulfato de dehidroepiandrosterona, androst-5-en-3beta, 17 beta-diol o 4androsten-3, 17-diona y un excipiente; kit; uso para tratar sintomas menopausicos como incontinencia urinaria, vaginitis atrofica, sequedad vaginal, dispareunia y disfuncion sexual. | ⤷ Try a Trial |
Israel | 203747 | שימוש בפרקורסור של סטרויד מין בייצור תרופה למתן 13 מ" ג או פחות למינון יומי דרך הנרתיק לטיפול מחלות נרתיקיות ותכשיר רוקחי נרתיקי המכילה אותה (Use of sex steroid precursor in the manufacture of a medicament for delivering 13 mg or less daily dosage intrvaginally for the treatment of vaginal diseases and a vaginal pharmaceutical composition comprising same) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRASTERONE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2185157 | C02185157/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PRASTERON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67323 19.05.2020 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |