Lipfendra is a drug owned by Merck Sharp And Dohme Llc. It is protected by 1 US drug patent filed in 2026 out of which none have expired yet. Lipfendra's patents will be open to challenges from 15 July, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 04, 2040. Details of Lipfendra'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. | |||
| US11427616 | Pcsk9 Antagonist Compounds |
Feb, 2040
(13 years from now) | Active |
FDA has granted several exclusivities to Lipfendra. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Lipfendra, 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
Lipfendra.
Exclusivity Information
Lipfendra holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Lipfendra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 15, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Lipfendra 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 Lipfendra's family patents as well as insights into
ongoing legal events
on those patents.
Lipfendra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lipfendra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 04, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lipfendra Generics:
There are no approved generic versions for Lipfendra as of now.
About Lipfendra
Lipfendra is a drug owned by Merck Sharp And Dohme Llc. Lipfendra uses Enlicitide Decanoate as an active ingredient. Lipfendra was launched by Merck in 2026.
Approval Date:
Lipfendra was approved by FDA for market use on 15 July, 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 Lipfendra is 15 July, 2026, its NCE-1 date is estimated to be 15 July, 2030.
Active Ingredient:
Lipfendra uses Enlicitide Decanoate as the active ingredient. Check out other Drugs and Companies using Enlicitide Decanoate ingredient
Dosage:
Lipfendra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |