DROSPIRENONE; ESTETROL - Generic Drug Details
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What are the generic drug sources for drospirenone; estetrol and what is the scope of patent protection?
Drospirenone; estetrol
is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Drospirenone; estetrol has two hundred and two patent family members in forty-seven countries.
One supplier is listed for this compound.
Summary for DROSPIRENONE; ESTETROL
| International Patents: | 202 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 10 |
| DailyMed Link: | DROSPIRENONE; ESTETROL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DROSPIRENONE; ESTETROL
Generic Entry Date for DROSPIRENONE; ESTETROL*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*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 DROSPIRENONE; ESTETROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 4 |
| Quotient Sciences | Phase 1 |
| Estetra | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ESTETROL
US Patents and Regulatory Information for DROSPIRENONE; ESTETROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 DROSPIRENONE; ESTETROL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Estetra SPRL | Lydisilka | estetrol, drospirenone | EMEA/H/C/005382 Oral contraception.The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). |
Authorised | no | no | no | 2021-05-19 | |
| Gedeon Richter Plc. | Drovelis | estetrol, drospirenone | EMEA/H/C/005336 oral contraceptive |
Authorised | no | no | no | 2021-05-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DROSPIRENONE; ESTETROL
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Tunisia | 2017000499 | ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT | ⤷ Sign Up |
| Morocco | 45972 | Unité posologique orodispersible contenant un composant d'estétrol | ⤷ Sign Up |
| Spain | 2260441 | ⤷ Sign Up | |
| Spain | 2906228 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DROSPIRENONE; ESTETROL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | 04C0022 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 3701944 | PA2022508,C3701944 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519 |
| 3701944 | PA2022508 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519 |
| 3632448 | 22C1031 | France | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
