Lynavoy is a drug owned by Glaxosmithkline Llc. It is protected by 1 US drug patent filed in 2026 out of which none have expired yet. Lynavoy's patents will be open to challenges from 17 March, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 17, 2033. Details of Lynavoy'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. | |||
| US9040518 | Chemical Compounds |
Sep, 2031
(5 years from now) | Active |
FDA has granted several exclusivities to Lynavoy. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Lynavoy, 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
Lynavoy.
Exclusivity Information
Lynavoy holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2033. Details of Lynavoy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 17, 2031 |
| Orphan Drug Exclusivity(ODE-517) | Mar 17, 2033 |
US patents provide insights into the exclusivity only within the United States, but
Lynavoy 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 Lynavoy's family patents as well as insights into
ongoing legal events
on those patents.
Lynavoy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lynavoy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 17, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lynavoy Generics:
There are no approved generic versions for Lynavoy as of now.
About Lynavoy
Lynavoy is a drug owned by Glaxosmithkline Llc. Lynavoy uses Linerixibat as an active ingredient. Lynavoy was launched by Glaxosmithkline in 2026.
Approval Date:
Lynavoy was approved by FDA for market use on 17 March, 2026.
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 Lynavoy is 17 March, 2026, its NCE-1 date is estimated to be 17 March, 2030.
Active Ingredient:
Lynavoy uses Linerixibat as the active ingredient. Check out other Drugs and Companies using Linerixibat ingredient
Dosage:
Lynavoy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG | TABLET | Prescription | ORAL |