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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fuji
Mallinckrodt
Julphar
Fish and Richardson
Queensland Health
AstraZeneca
US Army
Moodys
Express Scripts

Generated: November 21, 2017

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Somatropin recombinant - Generic Drug Details

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What are the generic drug sources for somatropin recombinant and what is the scope of somatropin recombinant patent protection?

Somatropin recombinant
is the generic ingredient in twenty branded drugs marketed by Emd Serono, Lg Chem Ltd, 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.

Somatropin recombinant has two hundred and eleven patent family members in twenty-eight countries.

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

Summary for somatropin recombinant

Pharmacology for somatropin recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
HUMATROPE
somatropin recombinant
INJECTABLE;INJECTION019640-001Jun 23, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Emd Serono
ZORBTIVE
somatropin recombinant
INJECTABLE;INJECTION021597-001Dec 1, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Emd Serono
SAIZEN
somatropin recombinant
INJECTABLE;INJECTION019764-001Oct 8, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-001Jan 27, 1998RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-009Mar 1, 2010BXRXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-008Mar 1, 2010BXRXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-011Jan 23, 2015RXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-011Jan 23, 2015RXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-010Mar 1, 2010RXNoNo► Subscribe► SubscribeY ► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-013Jan 27, 1998RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: somatropin recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
ZORBTIVE
somatropin recombinant
INJECTABLE;INJECTION021597-004Dec 1, 2003► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-012Jan 27, 1998► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-013Jan 27, 1998► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-011Jan 23, 2015► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-005Jan 27, 1998► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-009Jan 27, 1998► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-003Jan 27, 1998► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-007Mar 10, 2009► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-001Jan 27, 1998► Subscribe► Subscribe
Pharmacia And Upjohn
GENOTROPIN PRESERVATIVE FREE
somatropin recombinant
INJECTABLE;INJECTION020280-012Jan 27, 1998► Subscribe► Subscribe
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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
8,096,978Automatic injection device with a top release mechanism► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
6,582,404 Dose setting limiter► Subscribe
7,686,786Dial-down mechanism for wind-up pen► Subscribe
9,616,180Automatic injection device with a top release mechanism► Subscribe
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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
Hungary222513► Subscribe
European Patent Office1843809► Subscribe
Austria444090► Subscribe
Canada2383078► Subscribe
Japan2000508665► Subscribe
Japan5568157► Subscribe
Russian Federation2007114760► Subscribe
Poland329386► Subscribe
China100571805► Subscribe
World Intellectual Property Organization (WIPO)2006076921► Subscribe
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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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
McKinsey
QuintilesIMS
UBS
Federal Trade Commission
Fish and Richardson
Mallinckrodt
Dow
McKesson
Chubb

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 verifification 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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