Lynkuet is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 5 US drug patents filed in 2025 out of which none have expired yet. Lynkuet's patents will be open to challenges from 24 October, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 13, 2039. Details of Lynkuet'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. | |||
| US7683056 | NA |
Sep, 2026
(8 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12264164 | NA |
Mar, 2039
(13 years from now) | Active |
| US11787820 | NA |
Mar, 2039
(13 years from now) | Active |
| US10774091 | NA |
Mar, 2039
(13 years from now) | Active |
| US10195205 | NA |
May, 2036
(10 years from now) | Active |
FDA has granted several exclusivities to Lynkuet. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Lynkuet, 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
Lynkuet.
Exclusivity Information
Lynkuet holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Lynkuet's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 24, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Lynkuet 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 Lynkuet's family patents as well as insights into
ongoing legal events
on those patents.
Lynkuet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lynkuet's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 13, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lynkuet Generics:
There are no approved generic versions for Lynkuet as of now.
Alternative Brands for Lynkuet
There are several other brand drugs in the same treatment category as Lynkuet. 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 | Treatment Area | ||
|---|---|---|---|---|
| Astellas |
| |||
About Lynkuet
Lynkuet is a drug owned by Bayer Healthcare Pharmaceuticals Inc. Lynkuet uses Elinzanetant as an active ingredient. Lynkuet was launched by Bayer Hlthcare in 2025.
Approval Date:
Lynkuet was approved by FDA for market use on 24 October, 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 Lynkuet is 24 October, 2025, its NCE-1 date is estimated to be 24 October, 2029.
Active Ingredient:
Lynkuet uses Elinzanetant as the active ingredient. Check out other Drugs and Companies using Elinzanetant ingredient
Dosage:
Lynkuet is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG | CAPSULE | Prescription | ORAL |