Sunlenca is a drug owned by Gilead Sciences Inc. It is protected by 5 US drug patents filed from 2023 to 2024 out of which none have expired yet. Sunlenca's patents will be open to challenges from 22 December, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 04, 2041. Details of Sunlenca'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. | |||
| US11944611 | Capsid inhibitors for the treatment of HIV |
Jun, 2041
(16 years from now) | Active |
| US11267799 | Solid forms of an HIV capsid inhibitor |
Aug, 2038
(13 years from now) | Active |
| US10071985 | Therapeutic compounds |
Aug, 2037
(12 years from now) | Active |
| US9951043 | Therapeutic compounds |
Feb, 2034
(9 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11944611 | Capsid inhibitors for the treatment of HIV |
Jun, 2041
(16 years from now) | Active |
| US10654827 | Therapeutic compounds |
Aug, 2037
(12 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 Sunlenca's patents.
Latest Legal Activities on Sunlenca's Patents
Given below is the list of recent legal activities going on the following patents of Sunlenca.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Electronic Review Critical | 07 Jun, 2024 | US11944611 |
| Petition Entered | 30 May, 2024 | US11944611 |
| Second letter to regulating agency to determine regulatory review period | 10 May, 2024 | US9951043 |
| Recordation of Patent eGrant | 02 Apr, 2024 | US11944611 |
| Recordation of Patent Grant Mailed Critical | 02 Apr, 2024 | US11944611 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Apr, 2024 | US11944611 |
| Patent eGrant Notification | 02 Apr, 2024 | US11944611 |
| Email Notification Critical | 02 Apr, 2024 | US11944611 |
| Mail Patent eGrant Notification | 02 Apr, 2024 | US11944611 |
| Email Notification Critical | 14 Mar, 2024 | US11944611 |
FDA has granted several exclusivities to Sunlenca. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sunlenca, 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 Sunlenca.
Exclusivity Information
Sunlenca holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Sunlenca's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 22, 2027 |
US patents provide insights into the exclusivity only within the United States, but Sunlenca 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 Sunlenca's family patents as well as insights into ongoing legal events on those patents.
Sunlenca's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sunlenca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 04, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sunlenca Generics:
There are no approved generic versions for Sunlenca as of now.
About Sunlenca
Sunlenca is a drug owned by Gilead Sciences Inc. It is used for treating HIV-1 infection with multidrug resistance in heavily treatment-experienced adults when combined with other antiretrovirals. Sunlenca uses Lenacapavir Sodium as an active ingredient. Sunlenca was launched by Gilead Sciences Inc in 2022.
Approval Date:
Sunlenca was approved by FDA for market use on 22 December, 2022.
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 Sunlenca is 22 December, 2022, its NCE-1 date is estimated to be 22 December, 2026.
Active Ingredient:
Sunlenca uses Lenacapavir Sodium as the active ingredient. Check out other Drugs and Companies using Lenacapavir Sodium ingredient
Treatment:
Sunlenca is used for treating HIV-1 infection with multidrug resistance in heavily treatment-experienced adults when combined with other antiretrovirals.
Dosage:
Sunlenca is available in the following dosage forms - tablet form for oral use, solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| EQ 300MG BASE | TABLET | Prescription | ORAL |