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.
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: | 2,197 |
| What excipients (inactive ingredients) are in SOMATULINE DEPOT? | SOMATULINE DEPOT excipients list |
| DailyMed Link: | SOMATULINE DEPOT at DailyMed |
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 |
|---|---|
| University Hospital, Antwerp | Phase 4 |
| Belgium Health Care Knowledge Centre | Phase 4 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Phase 4 |
Pharmacology for SOMATULINE DEPOT
| Drug Class | Somatostatin Analog |
| Mechanism of Action | Somatostatin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ Try a Trial.
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-002 | Aug 30, 2007 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-003 | Aug 30, 2007 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-001 | Aug 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-002 | Aug 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 | 230977 | ⤷ Try a Trial | |
| Austria | 306906 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 9607440 | ⤷ Try a Trial | |
| South Korea | 20030096433 | ⤷ Try a Trial | |
| Germany | 69535322 | ⤷ Try a Trial | |
| >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 | ⤷ Try a Trial | 91037, EXPIRES: 20160511 |
| 0779805 | CA 2002 00032 | Denmark | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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