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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Questions you can ask:
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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: | 13 |
Clinical Trials: | 27 |
Patent Applications: | 1,802 |
What excipients (inactive ingredients) are in SOMATULINE DEPOT? | SOMATULINE DEPOT excipients list |
DailyMed Link: | SOMATULINE DEPOT at DailyMed |
![SOMATULINE DEPOT drug patent expirations Drug patent expirations by year for SOMATULINE DEPOT](/p/graph/s/t/SOMATULINE_DEPOT-patent-expirations.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
Erasmus Medical Center | Phase 4 |
University Hospital, Antwerp | Phase 4 |
Belgium Health Care Knowledge Centre | Phase 4 |
Pharmacology for SOMATULINE DEPOT
Drug Class | Somatostatin Analog |
Mechanism of Action | Somatostatin Receptor Agonists |
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 ⤷ Sign Up.
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: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-002 | Aug 30, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-003 | Aug 30, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | 022074-001 | Aug 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-003 | Aug 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-002 | Aug 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Austria | 306906 | ⤷ Sign Up | |
China | 1212830 | ⤷ Sign Up | |
Spain | 2141956 | ⤷ Sign Up | |
European Patent Office | 1595532 | ⤷ Sign Up | |
Germany | 69535645 | ⤷ Sign Up | |
Australia | 712916 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SOMATULINE DEPOT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0779805 | CA 2002 00032 | Denmark | ⤷ Sign Up | |
0779805 | 91037 | Luxembourg | ⤷ Sign Up | 91037, EXPIRES: 20160511 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |