Somatuline Depot is a drug owned by Ipsen Pharma Biotech Sas. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Somatuline Depot's patents have been open to challenges since 31 August, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2024. Details of Somatuline Depot's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5595760 | Sustained release of peptides from pharmaceutical compositions |
Mar, 2020
(4 years ago) |
Expired
|
FDA has granted several exclusivities to Somatuline Depot. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Somatuline Depot, 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 Somatuline Depot.
Exclusivity Information
Somatuline Depot holds 7 exclusivities. All of its exclusivities have expired in 2024. Details of Somatuline Depot's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 30, 2012 |
| New Dosing Schedule(D-131) | Mar 04, 2014 |
| Orphan Drug Exclusivity(ODE) | Aug 30, 2014 |
| New Indication(I-701) | Dec 19, 2017 |
| New Indication(I-754) | Sep 15, 2020 |
| Orphan Drug Exclusivity(ODE-82) | Dec 16, 2021 |
| Orphan Drug Exclusivity(ODE-156) | Sep 15, 2024 |
US patents provide insights into the exclusivity only within the United States, but Somatuline Depot 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 Somatuline Depot's family patents as well as insights into ongoing legal events on those patents.
Somatuline Depot's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Somatuline Depot's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 15, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Somatuline Depot Generic API suppliers:
Lanreotide Acetate is the generic name for the brand Somatuline Depot. 1 company has already filed for the generic of Somatuline Depot. Check out the entire list of companies who have already received approval for Somatuline Depot's generic
About Somatuline Depot
Somatuline Depot is a drug owned by Ipsen Pharma Biotech Sas. It is used for treating acromegaly and neuroendocrine tumors. Somatuline Depot uses Lanreotide Acetate as an active ingredient. Somatuline Depot was launched by Ipsen Pharma in 2007.
Approval Date:
Somatuline Depot was approved by FDA for market use on 30 August, 2007.
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 Somatuline Depot is 30 August, 2007, its NCE-1 date is estimated to be 31 August, 2011.
Active Ingredient:
Somatuline Depot uses Lanreotide Acetate as the active ingredient. Check out other Drugs and Companies using Lanreotide Acetate ingredient
Treatment:
Somatuline Depot is used for treating acromegaly and neuroendocrine tumors.
Dosage:
Somatuline Depot is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |