Yeztugo is a drug owned by Gilead Sciences Inc. It is protected by 4 US drug patents filed in 2025 out of which none have expired yet. Yeztugo'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 Nov 25, 2040. Details of Yeztugo'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. | |||
| US11267799 | Solid forms of an HIV capsid inhibitor |
Aug, 2038
(12 years from now) | Active |
| US10071985 | Therapeutic compounds |
Aug, 2037
(11 years from now) | Active |
| US9951043 | Therapeutic compounds |
Feb, 2034
(7 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). | |||
| US11807625 | Capsid Inhibitors For The Prevention Of Hiv |
Nov, 2040
(14 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 Yeztugo's patents.
Latest Legal Activities on Yeztugo's Patents
Given below is the list of recent legal activities going on the following patents of Yeztugo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Aug, 2025 | US11267799 |
| Information Disclosure Statement (IDS) Filed | 12 May, 2025 | US9951043 |
| transaction for FDA Determination of Regulatory Review Period | 12 May, 2025 | US9951043 |
| transaction for FDA Determination of Regulatory Review Period | 26 Mar, 2025 | US9951043 |
| Second letter to regulating agency to determine regulatory review period | 10 May, 2024 | US9951043 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US9951043 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9951043 |
| Email Notification | 07 Nov, 2023 | US11807625 |
| Patent Issue Date Used in PTA Calculation | 07 Nov, 2023 | US11807625 |
| Recordation of Patent eGrant | 07 Nov, 2023 | US11807625 |
FDA has granted several exclusivities to Yeztugo. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Yeztugo, 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
Yeztugo.
Exclusivity Information
Yeztugo holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Yeztugo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 22, 2027 |
| New Product(NP) | Jun 18, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Yeztugo 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 Yeztugo's family patents as well as insights into
ongoing legal events
on those patents.
Yeztugo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Yeztugo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 25, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Yeztugo Generics:
There are no approved generic versions for Yeztugo as of now.
Alternative Brands for Yeztugo
There are several other brand drugs using the same active ingredient (Lenacapavir Sodium) as Yeztugo. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Gilead Sciences Inc |
|
About Yeztugo
Yeztugo is a drug owned by Gilead Sciences Inc. Yeztugo uses Lenacapavir Sodium as an active ingredient. Yeztugo was launched by Gilead in 2025.
Approval Date:
Yeztugo was approved by FDA for market use on 18 June, 2025.
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 Yeztugo is 18 June, 2025, its NCE-1 date is estimated to be 22 December, 2026.
Active Ingredient:
Yeztugo uses Lenacapavir Sodium as the active ingredient. Check out other Drugs and Companies using Lenacapavir Sodium ingredient
Dosage:
Yeztugo 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 |