Iqirvo is a drug owned by Ipsen Biopharmaceuticals Inc. It is protected by 6 US drug patents filed in 2024. Out of these, 4 drug patents are active and 2 have expired. Iqirvo's patents will be open to challenges from 10 June, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 30, 2037. Details of Iqirvo'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. | |||
| US7943661 | Substituted 1,3-diphenylprop-2-en-1-one derivatives and preparation and uses thereof |
Sep, 2024
(3 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11857523 | Methods of treatment of cholestatic diseases |
Mar, 2037
(12 years from now) | Active |
| US11850223 | Methods of treatment of cholestatic diseases |
Mar, 2037
(12 years from now) | Active |
| US11331292 | Methods of treatment of cholestatic diseases |
Mar, 2037
(12 years from now) | Active |
| US11185519 | Methods of treatment of cholestatic diseases |
Mar, 2037
(12 years from now) | Active |
| US7632870 | Composition based on substituted 1,3-diphenylprop-2-en-1-one derivatives, preparation and uses thereof |
Sep, 2024
(3 months ago) |
Expired
|
FDA has granted several exclusivities to Iqirvo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Iqirvo, 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 Iqirvo.
Exclusivity Information
Iqirvo holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Iqirvo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 10, 2029 |
| Orphan Drug Exclusivity(ODE-486) | Jun 10, 2031 |
US patents provide insights into the exclusivity only within the United States, but Iqirvo 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 Iqirvo's family patents as well as insights into ongoing legal events on those patents.
Iqirvo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Iqirvo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 30, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Iqirvo Generics:
There are no approved generic versions for Iqirvo as of now.
Alternative Brands for Iqirvo
There are several other brand drugs in the same treatment category as Iqirvo. 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 | ||
|---|---|---|---|---|
| Intercept Pharms Inc |
| |||
About Iqirvo
Iqirvo is a drug owned by Ipsen Biopharmaceuticals Inc. Iqirvo uses Elafibranor as an active ingredient. Iqirvo was launched by Ipsen in 2024.
Approval Date:
Iqirvo was approved by FDA for market use on 10 June, 2024.
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 Iqirvo is 10 June, 2024, its NCE-1 date is estimated to be 10 June, 2028.
Active Ingredient:
Iqirvo uses Elafibranor as the active ingredient. Check out other Drugs and Companies using Elafibranor ingredient
Dosage:
Iqirvo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 80MG | TABLET | Prescription | ORAL |