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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Citi
UBS
Teva
Medtronic
Cerilliant
Argus Health
QuintilesIMS
Chubb

Generated: May 28, 2018

DrugPatentWatch Database Preview

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 eighteen branded drugs marketed by Emergent, Pharmacia And Upjohn, Lilly, Novo Nordisk Inc, Genentech, Sandoz, Emd Serono, and Lg Chem Ltd, and is included in thirteen NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Somatropin recombinant has one hundred and eighty-seven patent family members in twenty-seven countries.

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

US Patents and Regulatory Information 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
Genentech NUTROPIN AQ NUSPIN somatropin recombinant INJECTABLE;INJECTION 020522-003 Jan 3, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Emd Serono SEROSTIM somatropin recombinant INJECTABLE;INJECTION 020604-003 Jul 25, 1997 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin recombinant INJECTABLE;INJECTION 020280-011 Jan 27, 1998 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-004 Mar 8, 1987 BX RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for somatropin recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono SEROSTIM somatropin recombinant INJECTABLE;INJECTION 020604-003 Jul 25, 1997 ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin recombinant INJECTABLE;INJECTION 020280-010 Jan 27, 1998 ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin recombinant INJECTABLE;INJECTION 020280-012 Jan 27, 1998 ➤ Sign Up ➤ Sign Up
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin recombinant INJECTABLE;INJECTION 020280-010 Jan 27, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Sign Up
7,686,786 Dial-down mechanism for wind-up pen ➤ Sign Up
8,096,978 Automatic injection device with a top release mechanism ➤ Sign Up
9,861,757 Injection device with an end of dose feedback mechanism ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cerilliant
Boehringer Ingelheim
Accenture
Express Scripts
Daiichi Sankyo
Chubb
Healthtrust
Queensland Health

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.