Addyi is a drug owned by Sprout Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2015 to 2016. Out of these, 1 drug patents are active and 3 have expired. Addyi's patents have been open to challenges since 19 August, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be May 09, 2028. Details of Addyi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7420057 | Stable polymorph of flibanserin |
Aug, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7151103 | Method of treating female hypoactive sexual desire disorder with flibanserin |
May, 2028
(3 years from now) | Active |
| US8227471 | Treating sexual desire disorders with flibanserin |
May, 2023
(1 year, 7 months ago) |
Expired
|
| US9468639 | Treating sexual desire disorders with flibanserin |
Oct, 2022
(2 years ago) |
Expired
|
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 Addyi's patents.
Latest Legal Activities on Addyi's Patents
Given below is the list of recent legal activities going on the following patents of Addyi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Jan, 2024 | US8227471 |
| Patent Term Extension Certificate Critical | 19 Nov, 2021 | US7151103 |
| FITF set to NO - revise initial setting | 05 Mar, 2021 | US7151103 |
| Notice of Final Determination -Election Required | 05 Mar, 2021 | US7151103 |
| Notice of Final Determination -Election Required | 05 Mar, 2021 | US7420057 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Apr, 2020 | US9468639 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Feb, 2020 | US7420057 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Jan, 2020 | US8227471 |
| Change in Power of Attorney (May Include Associate POA) Critical | 08 Oct, 2019 | US7151103 |
| Email Notification Critical | 08 Oct, 2019 | US7151103 |
FDA has granted several exclusivities to Addyi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Addyi, 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 Addyi.
Exclusivity Information
Addyi holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Addyi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 18, 2020 |
US patents provide insights into the exclusivity only within the United States, but Addyi 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 Addyi's family patents as well as insights into ongoing legal events on those patents.
Addyi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Addyi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 09, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Addyi Generics:
There are no approved generic versions for Addyi as of now.
About Addyi
Addyi is a drug owned by Sprout Pharmaceuticals Inc. It is used for treating hypoactive sexual desire disorder (HSDD). Addyi uses Flibanserin as an active ingredient. Addyi was launched by Sprout Pharms in 2015.
Approval Date:
Addyi was approved by FDA for market use on 18 August, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Addyi is 18 August, 2015, its NCE-1 date is estimated to be 19 August, 2019.
Active Ingredient:
Addyi uses Flibanserin as the active ingredient. Check out other Drugs and Companies using Flibanserin ingredient
Treatment:
Addyi is used for treating hypoactive sexual desire disorder (HSDD).
Dosage:
Addyi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |