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Last Updated: May 17, 2022

SOMATULINE DEPOT Drug Patent Profile


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Which patents cover Somatuline Depot, and what generic alternatives are available?

Somatuline Depot is a drug marketed by Ipsen Pharma and is included in one NDA.

The generic ingredient in SOMATULINE DEPOT is lanreotide acetate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Somatuline Depot

A generic version of SOMATULINE DEPOT was approved as lanreotide acetate by INVAGEN PHARMS on December 17th, 2021.

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Summary for SOMATULINE DEPOT
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 26
Patent Applications: 2,797
What excipients (inactive ingredients) are in SOMATULINE DEPOT?SOMATULINE DEPOT excipients list
DailyMed Link:SOMATULINE DEPOT at DailyMed
Drug patent expirations by year for SOMATULINE DEPOT
DrugPatentWatch® Estimated Generic Entry Opportunity Date for SOMATULINE DEPOT
Generic Entry Date for SOMATULINE DEPOT*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SOMATULINE DEPOT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Taiwan University HospitalPhase 1/Phase 2
Kaohsiung Medical University Chung-Ho Memorial HospitalPhase 1/Phase 2
Tri-Service General HospitalPhase 1/Phase 2

See all SOMATULINE DEPOT clinical trials

Pharmacology for SOMATULINE DEPOT

US Patents and Regulatory Information for SOMATULINE DEPOT

SOMATULINE DEPOT is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SOMATULINE DEPOT is See Plans and Pricing.

This potential generic entry date is based on TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting SOMATULINE DEPOT

TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-001 Aug 30, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-002 Aug 30, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-003 Aug 30, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SOMATULINE DEPOT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-003 Aug 30, 2007 See Plans and Pricing See Plans and Pricing
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-001 Aug 30, 2007 See Plans and Pricing See Plans and Pricing
Ipsen Pharma SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074-002 Aug 30, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SOMATULINE DEPOT

See the table below for patents covering SOMATULINE DEPOT around the world.

Country Patent Number Title Estimated Expiration
Spain 2248206 See Plans and Pricing
South Africa 9507355 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9607398 See Plans and Pricing
China 1212830 See Plans and Pricing
China 1165479 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Colorcon
Merck
Moodys
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.