Last Updated: June 9, 2026

Claims for Patent: 11,413,249

✉ Email this page to a colleague

« Back to Dashboard

Summary for Patent: 11,413,249

Title:	Synthetic progestogens and pharmaceutical compositions comprising the same
Abstract:	Described herein are synthetic progestogens, such as 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone, as well as pharmaceutical compositions comprising the same. Also described are methods of use.
Inventor(s):	Philippe Perrin, Jose Luis Velada, Dominique Drouin
Assignee:	Laboratorios Leon Farma SA
Application Number:	US17/693,243
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,413,249
Patent Claims:	1. A method of providing effective contraception in a female patient, the method comprising: orally administering to the patient a daily pharmaceutical composition for 24 consecutive days, followed by orally administering to the patient a daily placebo dosage unit for 4 consecutive days, wherein the pharmaceutical composition comprises from 2 mg to 6 mg drospirenone and is formulated such that: (1) when orally administered under fasting conditions, the pharmaceutical composition provides a pharmacokinetic profile for the drospirenone comprising: (i) a mean Tmax ranging from 2.2 hours to 6 hours; (ii) a mean Cmax which is less than 30 ng/ml; and (iii) a mean AUC0h-tlast of at least 300 ngh/ml; and (2) no more than 50% of the drospirenone initially present in the pharmaceutical composition is dissolved within 30 minutes if subjected to an in vitro dissolution test according to the USP XXIII Paddle Method; and wherein the pharmaceutical composition does not comprise estrogen. 2. The method of claim 1, wherein the mean Tmax ranges from 3 hours to 4 hours. 3. The method of claim 1, wherein the mean Cmax ranges from 15 ng/ml to less than 30 ng/ml. 4. The method of claim 1, wherein the mean AUC0h-tlast is at least 350 ngh/ml. 5. The method of claim 1, wherein the pharmaceutical composition is formulated such that at least 55% of the drospirenone initially present in the pharmaceutical composition is dissolved within 4 hours if subjected to the in vitro dissolution test according to the USP XXIII Paddle Method. 6. The method of claim 1, wherein the amount of the drospirenone present is 3.5 mg. 7. The method of claim 1, wherein the amount of the drospirenone present is 4.0 mg. 8. The method of claim 1, wherein the amount of the drospirenone present ranges from 3.0 mg to 4.5 mg. 9. The method of claim 1, wherein the amount of the drospirenone present ranges from 3.0 mg to 3.5 mg. 10. The method of claim 1, wherein the amount of the drospirenone present ranges from 3.5 mg to 4.5 mg.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.