Imcivree is a drug owned by Rhythm Pharmaceuticals Inc. It is protected by 3 US drug patents filed in 2021 out of which none have expired yet. Imcivree's patents have been open to challenges since 25 November, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 04, 2034. Details of Imcivree'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. | |||
| US9458195 | Melanocortin receptor ligands |
Oct, 2027
(2 years from now) | Active |
| US8039435 | Melanocortin receptor ligands |
Oct, 2027
(2 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). | |||
| US11129869 | Pharmaceutical compositions |
Jul, 2034
(9 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 Imcivree's patents.
Latest Legal Activities on Imcivree's Patents
Given below is the list of recent legal activities going on the following patents of Imcivree.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Mar, 2024 | US9458195 |
| FDA Final Eligibility Letter Critical | 10 May, 2023 | US8039435 |
| FDA Final Eligibility Letter Critical | 10 May, 2023 | US9458195 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Apr, 2023 | US8039435 |
| transaction for FDA Determination of Regulatory Review Period | 01 Jul, 2022 | US8039435 |
| transaction for FDA Determination of Regulatory Review Period | 01 Jul, 2022 | US9458195 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jun, 2022 | US8039435 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jun, 2022 | US9458195 |
| Second letter to regulating agency to determine regulatory review period | 13 Jan, 2022 | US9458195 |
| Second letter to regulating agency to determine regulatory review period | 13 Jan, 2022 | US8039435 |
FDA has granted several exclusivities to Imcivree. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Imcivree, 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 Imcivree.
Exclusivity Information
Imcivree holds 7 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Imcivree's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-892) | Jun 16, 2025 |
| New Chemical Entity Exclusivity(NCE) | Nov 25, 2025 |
| Orphan Drug Exclusivity(ODE-336) | Nov 25, 2027 |
| New Patient Population(NPP) | Dec 20, 2027 |
| Orphan Drug Exclusivity(ODE-402) | Jun 16, 2029 |
| Orphan Drug Exclusivity(ODE-508) | Dec 20, 2031 |
| Orphan Drug Exclusivity(ODE-509) | Dec 20, 2031 |
Several oppositions have been filed on Imcivree'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 Imcivree's generic, the next section provides detailed information on ongoing and past EP oppositions related to Imcivree patents.
Imcivree's Oppositions Filed in EPO
Imcivree has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 18, 2021, by Sandoz Ag. This opposition was filed on patent number EP14724574A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14724574A | May, 2021 | SANDOZ AG | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Imcivree 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 Imcivree's family patents as well as insights into ongoing legal events on those patents.
Imcivree's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Imcivree's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 04, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Imcivree Generics:
There are no approved generic versions for Imcivree as of now.
About Imcivree
Imcivree is a drug owned by Rhythm Pharmaceuticals Inc. Imcivree uses Setmelanotide Acetate as an active ingredient. Imcivree was launched by Rhythm in 2020.
Approval Date:
Imcivree was approved by FDA for market use on 25 November, 2020.
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 Imcivree is 25 November, 2020, its NCE-1 date is estimated to be 25 November, 2024.
Active Ingredient:
Imcivree uses Setmelanotide Acetate as the active ingredient. Check out other Drugs and Companies using Setmelanotide Acetate ingredient
Dosage:
Imcivree is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE/ML (EQ 10MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |