Elucirem is a drug owned by Guerbet. It is protected by 3 US drug patents filed from 2022 to 2023 out of which none have expired yet. Elucirem's patents will be open to challenges from 21 September, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 17, 2040. Details of Elucirem'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. | |||
| US10973934 | Gadolinium bearing PCTA-based contrast agents |
Aug, 2039
(14 years from now) | Active |
| US8114863 | Compounds comprising short aminoalcohol chains and metal complexes for medical imaging |
Sep, 2028
(3 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). | |||
| US11590246 | Complex of gadolinium and a chelating ligand derived from a diastereoisomerically enriched PCTA and preparation and purification process |
Jan, 2040
(15 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 Elucirem's patents.
Latest Legal Activities on Elucirem's Patents
Given below is the list of recent legal activities going on the following patents of Elucirem.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 29 Feb, 2024 | US8114863 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US8114863 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Aug, 2023 | US8114863 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Feb, 2023 | US11590246 |
| Recordation of Patent Grant Mailed Critical | 28 Feb, 2023 | US11590246 |
| Email Notification Critical | 28 Feb, 2023 | US11590246 |
| Issue Notification Mailed Critical | 08 Feb, 2023 | US11590246 |
| Initial letter Re: PTE Application to regulating agency | 03 Feb, 2023 | US8114863 |
| Application Is Considered Ready for Issue Critical | 01 Feb, 2023 | US11590246 |
| Dispatch to FDC | 01 Feb, 2023 | US11590246 |
FDA has granted several exclusivities to Elucirem. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Elucirem, 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 Elucirem.
Exclusivity Information
Elucirem holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Elucirem's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 21, 2027 |
Several oppositions have been filed on Elucirem's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Elucirem's generic, the next section provides detailed information on ongoing and past EP oppositions related to Elucirem patents.
Elucirem's Oppositions Filed in EPO
Elucirem has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 02, 2021, by Cohausz & Florack Patent- Und Rechtsanwälte Partnerschaftsgesellschaft Mbb. This opposition was filed on patent number EP19753296A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19753296A | Aug, 2021 | COHAUSZ & FLORACK Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Elucirem 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 Elucirem's family patents as well as insights into ongoing legal events on those patents.
Elucirem's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Elucirem's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 17, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Elucirem Generics:
There are no approved generic versions for Elucirem as of now.
About Elucirem
Elucirem is a drug owned by Guerbet. Elucirem uses Gadopiclenol as an active ingredient. Elucirem was launched by Guerbet in 2022.
Approval Date:
Elucirem was approved by FDA for market use on 21 September, 2022.
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 Elucirem is 21 September, 2022, its NCE-1 date is estimated to be 21 September, 2026.
Active Ingredient:
Elucirem uses Gadopiclenol as the active ingredient. Check out other Drugs and Companies using Gadopiclenol ingredient
Dosage:
Elucirem is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 24.255GM/50ML (485.1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 1.4553GM/3ML (485.1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 14.553GM/30ML (485.1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 4.851GM/10ML (485.1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 7.2765GM/15ML (485.1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 48.51GM/100ML (485.1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 3.63825GM/7.5ML (485.1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |