Vyleesi (autoinjector) is a drug owned by Cosette Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2019 to 2023. Out of these, 5 drug patents are active and 1 has expired. Vyleesi (Autoinjector)'s patents have been open to challenges since 22 June, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 29, 2041. Details of Vyleesi (autoinjector)'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. | |||
| US6794489 | Compositions and methods for treatment of sexual dysfunction |
Jun, 2025
(6 months from now) | Active |
| US6579968 | Compositions and methods for treatment of sexual dysfunction |
Jun, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11590209 | Use of bremelanotide in patients with controlled hypertension |
Apr, 2041
(16 years from now) | Active |
| US9352013 | Uses of bremelanotide in therapy for female sexual dysfunction |
Nov, 2033
(8 years from now) | Active |
| US9700592 | Uses of bremelanotide in therapy for female sexual dysfunction |
Nov, 2033
(8 years from now) | Active |
| US10286034 | Uses of bremelanotide in therapy for female sexual dysfunction |
Nov, 2033
(8 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 Vyleesi (autoinjector)'s patents.
Latest Legal Activities on Vyleesi (autoinjector)'s Patents
Given below is the list of recent legal activities going on the following patents of Vyleesi (autoinjector).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 19 Nov, 2023 | US9352013 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 17 Nov, 2023 | US9352013 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Feb, 2023 | US11590209 |
| Recordation of Patent Grant Mailed Critical | 28 Feb, 2023 | US11590209 |
| Email Notification Critical | 28 Feb, 2023 | US11590209 |
| Issue Notification Mailed Critical | 08 Feb, 2023 | US11590209 |
| Dispatch to FDC | 26 Jan, 2023 | US11590209 |
| Application Is Considered Ready for Issue Critical | 26 Jan, 2023 | US11590209 |
| Issue Fee Payment Verified Critical | 24 Jan, 2023 | US11590209 |
| Issue Fee Payment Received Critical | 24 Jan, 2023 | US11590209 |
FDA has granted several exclusivities to Vyleesi (autoinjector). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vyleesi (autoinjector), 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 Vyleesi (autoinjector).
Exclusivity Information
Vyleesi (autoinjector) holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Vyleesi (autoinjector)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 21, 2024 |
Several oppositions have been filed on Vyleesi (autoinjector)'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 Vyleesi (autoinjector)'s generic, the next section provides detailed information on ongoing and past EP oppositions related to Vyleesi (autoinjector) patents.
Vyleesi (autoinjector)'s Oppositions Filed in EPO
Vyleesi (autoinjector) has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 18, 2019, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP13851014A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13851014A | Jun, 2019 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Vyleesi (autoinjector) 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 Vyleesi (autoinjector)'s family patents as well as insights into ongoing legal events on those patents.
Vyleesi (autoinjector)'s Family Patents
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Generic Launch
Generic Release Date:
Vyleesi (autoinjector)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 29, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vyleesi (autoinjector) Generics:
There are no approved generic versions for Vyleesi (autoinjector) as of now.
About Vyleesi (autoinjector)
Vyleesi (Autoinjector) is a drug owned by Cosette Pharmaceuticals Inc. It is used for treating hypoactive sexual desire disorder (HSDD) in premenopausal females with controlled hypertension by injecting bremelanotide. Vyleesi (Autoinjector) uses Bremelanotide Acetate as an active ingredient. Vyleesi (Autoinjector) was launched by Cosette in 2019.
Approval Date:
Vyleesi (autoinjector) was approved by FDA for market use on 21 June, 2019.
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 Vyleesi (autoinjector) is 21 June, 2019, its NCE-1 date is estimated to be 22 June, 2023.
Active Ingredient:
Vyleesi (autoinjector) uses Bremelanotide Acetate as the active ingredient. Check out other Drugs and Companies using Bremelanotide Acetate ingredient
Treatment:
Vyleesi (autoinjector) is used for treating hypoactive sexual desire disorder (HSDD) in premenopausal females with controlled hypertension by injecting bremelanotide.
Dosage:
Vyleesi (autoinjector) is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) | SOLUTION | Prescription | SUBCUTANEOUS |