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. Three 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: | 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 |
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.
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 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-002 | Aug 30, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-003 | Aug 30, 2007 | AB | 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 |
|---|---|---|---|
| Portugal | 1270032 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9607397 | ⤷ Sign Up | |
| Japan | H10508293 | ⤷ Sign Up | |
| Australia | 712916 | ⤷ Sign Up | |
| Germany | 69535645 | ⤷ Sign Up | |
| Spain | 2230431 | ⤷ Sign Up | |
| Japan | 4489186 | ⤷ 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 | 91037 | Luxembourg | ⤷ Sign Up | 91037, EXPIRES: 20160511 |
| 0779805 | CA 2002 00032 | Denmark | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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