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Profile for Tradename: NUTROPIN DEPOT

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Nutropin Depot is a drug marketed by Genentech and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and four patent family members in twenty-three countries.

The generic ingredient in NUTROPIN DEPOT is somatropin recombinant. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.

Summary for Tradename: NUTROPIN DEPOT


Clinical Trials for: NUTROPIN DEPOT

Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
Status: Terminated Condition: Growth Hormone Deficiency (GHD)

Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments
Status: Recruiting Condition: Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy

An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
Status: Active, not recruiting Condition: Adult Growth Hormone Deficiency

Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Status: Completed Condition: Turner's Syndrome; Human Growth Hormone Deficiency

Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
Status: Completed Condition: Growth Hormone Deficiency

Effects of Short-term Growth Hormone in HIV-infected Patients
Status: Completed Condition: HIV Lipodystrophy

Clinical Trial of Growth Hormone in MPS I, II, and VI
Status: Terminated Condition: Mucopolysaccharidosis I; Mucopolysaccharidosis II; Mucopolysaccharidosis VI

Observational Prospective Study on Patients Treated With Norditropin®
Status: Enrolling by invitation Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Adult Growth Hormone Deficiency; Genetic Disorder; Turner Syndrome; Foetal Growth Problem; Small for Gestational Age; Chronic Kidney Disease; Chronic Renal Insufficiency; Noonan Syndrome

Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Status: Completed Condition: Growth Hormone Deficiency

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
Status: Completed Condition: Healthy

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
somatropin recombinant
INJECTABLE;INJECTION021075-001Dec 22, 1999DISCNNo5,654,010<disabled> <disabled>
somatropin recombinant
INJECTABLE;INJECTION021075-002Dec 22, 1999DISCNNo5,654,010<disabled> <disabled>
somatropin recombinant
INJECTABLE;INJECTION021075-001Dec 22, 1999DISCNNo5,656,297<disabled> <disabled>
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Premature patent expiration for: NUTROPIN DEPOT

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
August 05, 2009
August 12, 2009

Non-Orange Book Patents for Tradename: NUTROPIN DEPOT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,514,533 Device for the sustained release of aggregation-stabilized, biologically active agent<disabled in preview>
5,912,015 Modulated release from biocompatible polymers<disabled in preview>
5,667,808 Composition for sustained release of human growth hormone<disabled in preview>
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International Patent Family for Tradename: NUTROPIN DEPOT

Country Document Number Publication Date
Canada2223583Dec 19, 1996
Hungary9900870Sep 28, 1999
Brazil9608542Nov 30, 1999
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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