Details for Patent: 12,427,114
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Which drugs does patent 12,427,114 protect, and when does it expire?
Patent 12,427,114 protects NEXTSTELLIS and is included in one NDA.
This patent has seventy-five patent family members in forty-two countries.
Summary for Patent: 12,427,114
| Title: | Orodispersible dosage unit containing an estetrol component |
| Abstract: | The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of:0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and75-99.9 wt. % of one or more pharmaceutically acceptable ingredients;the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm.The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration. |
| Inventor(s): | Séverine Francine Isabelle JASPART, Johannes Jan Platteeuw, Denny Johan Marijn Van Den Heuvel |
| Assignee: | Estetra SRL |
| Application Number: | US18/621,501 |
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Patent Claim Types: see list of patent claims | Use; Composition; Formulation; Process; Dosage form; |
Drugs Protected by US Patent 12,427,114
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | USE BY FEMALES OF REPRODUCTIVE POTENTIAL TO PREVENT PREGNANCY | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 12,427,114
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| European Patent Office | 3701944 | ⤷ Start Trial | PA2022508 | Lithuania | ⤷ Start Trial |
| European Patent Office | 3701944 | ⤷ Start Trial | PA2022508,C3701944 | Lithuania | ⤷ Start Trial |
| European Patent Office | 3701944 | ⤷ Start Trial | 202240021 | Slovenia | ⤷ Start Trial |
| Australia | 2016280858 | ⤷ Start Trial | |||
| Australia | 2021203265 | ⤷ Start Trial | |||
| Australia | 2022283615 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
