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Somatropin recombinant - Generic Drug Details

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Somatropin recombinant is the generic ingredient in twenty branded drugs marketed by Emd Serono, Lg Life, Novo Nordisk Inc, Genentech, Sandoz, Emergent, Lilly, Ferring, and Pharmacia And Upjohn, and is included in fourteen NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and thirty-four patent family members in thirty-three countries.

There are four drug master file entries for somatropin recombinant. Eight suppliers are listed for this compound.

Summary for Generic Name: somatropin recombinant

Tradenames:20
Patents:16
Applicants:9
NDAs:14
Drug Master File Entries: see list4
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details

Pharmacology for Ingredient: somatropin recombinant

Clinical Trials for: somatropin recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION021148-002Jun 20, 2000DISCNNo5,849,700<disabled> <disabled>
Emd Serono
SAIZEN
somatropin recombinant
INJECTABLE;INJECTION019764-002Oct 8, 1996RXNo5,898,030<disabled>Y <disabled>
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-009Mar 1, 2010RXNo8,672,898<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: somatropin recombinant

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-004Aug 24, 19955,633,352<disabled>
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-002Dec 22, 19995,912,015<disabled>
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-001Jan 27, 19985,435,076<disabled>
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Non-Orange Book Patents for Generic Ingredient: somatropin recombinant

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
6,582,404 Dose setting limiter<disabled in preview>
8,357,120Injection device with torsion spring and rotatable display<disabled in preview>
6,022,858 Pharmaceutical formulation of human-growth hormone pretreated with zinc salt<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: somatropin recombinant

Country Document Number Estimated Expiration
Spain2185625<disabled in preview>
Japan2008231124<disabled in preview>
Russian Federation94045932<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SOMATROPIN RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C008/2003Ireland<disabled>SPC008/2003: 20030508, EXPIRES: 20121217
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