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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Drospirenone; estetrol has one hundred and fifty-seven patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for drospirenone; estetrol
| International Patents: | 157 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 9 |
| 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 |
|---|---|
| Quotient Sciences | Phase 1 |
| Estetra | Phase 2 |
| Estetra | Phase 1/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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | 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 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 |
|---|---|---|---|
| Serbia | 73304 | ⤷ Try a Trial | |
| European Patent Office | 1446128 | UTILISATION DE COMPOSES OESTROGENES COMBINES A DES COMPOSES PROGESTOGENES EN THERAPIE DE SUBSTITUTION HORMONALE (USE OF ESTROGENIC COMPOUNDS IN COMBINATION WITH PROGESTOGENIC COMPOUNDS IN HORMONE-REPLACEMENT THERAPY) | ⤷ Try a Trial |
| European Patent Office | 3701944 | UNITÉ POSOLOGIQUE ORODISPERSIBLE CONTENANT UN COMPOSANT D'ESTÉTROL (ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT) | ⤷ Try a Trial |
| Israel | 163579 | KIT FOR USE IN HORMONAL CONTRACEPTIVE METHOD OR HORMONE REPLACEMENT THERAPY | ⤷ Try a Trial |
| Eurasian Patent Organization | 007599 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ОДИН ИЛИ НЕСКОЛЬКО СТЕРОИДОВ, ОДИН ИЛИ НЕСКОЛЬКО ТЕТРАГИДРОФОЛАТНЫХ КОМПОНЕНТОВ И ВИТАМИН В (PHARMACEUTICAL COMPOSITIONS COMPRISING ONE OR MORE STEROIDS ONE OR MORE TETRAHYDROPOLATE COMPONENTS AND VITAMIN B) | ⤷ Try a Trial |
| Eurasian Patent Organization | 200401014 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for drospirenone; estetrol
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | SPC/GB04/032 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| 3701944 | PA2022508 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519 |
| 2588114 | LUC00227 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022 |
| 3632448 | LUC00266 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401 |
| 3632448 | 22C1031 | France | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016 |
| 3701944 | PA2022508,C3701944 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
