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Last Updated: November 30, 2022

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: 47
Clinical Trials: 4
Patent Applications: 5,787
What excipients (inactive ingredients) are in lanreotide acetate?lanreotide acetate excipients list
DailyMed Link:lanreotide acetate at DailyMed
Recent Clinical Trials for lanreotide acetate

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

SponsorPhase
Debiopharm International SAPhase 1
IpsenPhase 1/Phase 2
IpsenPhase 3

See all lanreotide acetate clinical trials

Pharmacology for lanreotide acetate

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
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
Invagen Pharms LANREOTIDE ACETATE lanreotide acetate SOLUTION;SUBCUTANEOUS 215395-002 Dec 17, 2021 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
Invagen Pharms LANREOTIDE ACETATE lanreotide acetate SOLUTION;SUBCUTANEOUS 215395-003 Dec 17, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Invagen Pharms LANREOTIDE ACETATE lanreotide acetate SOLUTION;SUBCUTANEOUS 215395-001 Dec 17, 2021 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 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 See Plans and Pricing See Plans and Pricing
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 022074-002 Aug 30, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Dow

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