Drospirenone is a drug owned by Exeltis Usa Inc. It is protected by 14 US drug patents filed from 2022 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 28, 2031. Details of Drospirenone's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9603860 | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
Jun, 2031
(6 years from now) | Active |
| US10179140 | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
Jun, 2031
(6 years from now) | Active |
| US11413249 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US11951213 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US11351122 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US11123299 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US11439598 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US11291633 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US10987364 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US11291632 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US11504334 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
| US10849857 | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
Jun, 2031
(6 years from now) | Active |
| US10603281 | Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same |
Jun, 2031
(6 years from now) | Active |
| US11478487 | Synthetic progestogens and pharmaceutical compositions comprising the same |
Jun, 2031
(6 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Drospirenone's patents.
Latest Legal Activities on Drospirenone's Patents
Given below is the list of recent legal activities going on the following patents of Drospirenone.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jun, 2024 | US10849857 |
| Patent Issue Date Used in PTA Calculation | 09 Apr, 2024 | US11951213 |
| Email Notification | 09 Apr, 2024 | US11951213 |
| Recordation of Patent eGrant | 09 Apr, 2024 | US11951213 |
| Patent eGrant Notification | 09 Apr, 2024 | US11951213 |
| Mail Patent eGrant Notification | 09 Apr, 2024 | US11951213 |
| Recordation of Patent Grant Mailed | 09 Apr, 2024 | US11951213 |
| Email Notification | 21 Mar, 2024 | US11951213 |
| Issue Notification Mailed | 20 Mar, 2024 | US11951213 |
| Dispatch to FDC | 01 Mar, 2024 | US11951213 |
FDA has granted several exclusivities to Drospirenone. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Drospirenone, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Drospirenone.
Exclusivity Information
Drospirenone holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Drospirenone's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 29, 2025 |
Several oppositions have been filed on Drospirenone's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Drospirenone's generic, the next section provides detailed information on ongoing and past EP oppositions related to Drospirenone patents.
Drospirenone's oppositions filed in EPO
Drospirenone has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 12, 2022, by Adalvo Ltd.. This opposition was filed on patent number EP19209672A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19209672A | Oct, 2022 | Luigi, Rumi | Granted and Under Opposition |
| EP19209672A | Oct, 2022 | Adalvo Ltd. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Drospirenone is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Drospirenone's family patents as well as insights into ongoing legal events on those patents.
Drospirenone's family patents
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Generic Launch
Generic Release Date:
Drospirenone's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 28, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Drospirenone Generics:
There are no approved generic versions for Drospirenone as of now.
About Drospirenone
Drospirenone is a drug owned by Exeltis Usa Inc. It is used for preventing pregnancy in females of reproductive age. Drospirenone uses Drospirenone as an active ingredient. Drospirenone was launched by Exeltis Usa Inc in 2022.
Can you believe Drospirenone received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Market Authorisation Date:
Drospirenone was approved by FDA for market use on 29 June, 2022.
Active Ingredient:
Drospirenone uses Drospirenone as the active ingredient. Check out other Drugs and Companies using Drospirenone ingredient
Treatment:
Drospirenone is used for preventing pregnancy in females of reproductive age.
Dosage:
Drospirenone is available in tablet, chewable form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3.5MG | TABLET, CHEWABLE | Discontinued | ORAL |