Somatuline Depot Patent Expiration

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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


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 Generics:

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