Lanreotide acetate - Generic Drug Details
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What are the generic sources for lanreotide acetate and what is the scope of freedom to operate?
Lanreotide acetate
is the generic ingredient in two branded drugs marketed by Invagen Pharms and Ipsen Pharma, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for lanreotide acetate. Two suppliers are listed for this compound.
Summary for lanreotide acetate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 4 |
| Patent Applications: | 5,960 |
| What excipients (inactive ingredients) are in lanreotide acetate? | lanreotide acetate excipients list |
| DailyMed Link: | lanreotide acetate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lanreotide acetate
Generic Entry Date for lanreotide acetate*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY 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 lanreotide acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Debiopharm International SA | Phase 1 |
| Ipsen | Phase 1/Phase 2 |
| Ipsen | Phase 3 |
Pharmacology for lanreotide acetate
| Drug Class | Somatostatin Analog |
| Mechanism of Action | Somatostatin Receptor Agonists |
US Patents and Regulatory Information for lanreotide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Invagen Pharms | LANREOTIDE ACETATE | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 215395-001 | Dec 17, 2021 | 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 | ||||
| Invagen Pharms | LANREOTIDE ACETATE | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 215395-003 | Dec 17, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Invagen Pharms | LANREOTIDE ACETATE | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 215395-002 | Dec 17, 2021 | 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 lanreotide acetate
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| 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 | 022074-002 | Aug 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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