Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 6, 2019

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Somatropin - Generic Drug Details

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

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

Somatropin has one hundred and ninety-eight patent family members in twenty-two countries.

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

Summary for somatropin
Drug Prices for somatropin

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Recent Clinical Trials for somatropin

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SponsorPhase
Parc de Salut MarPhase 1
LG ChemPhase 1
Ache Laboratorios Farmaceuticos S.A.Phase 4

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Pharmacology for somatropin

US Patents and Regulatory Information for somatropin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-002 Jun 20, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-013 Jan 27, 1998 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-010 Mar 1, 2010 RX No No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-011 Jan 23, 2015 RX No No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-011 Jan 23, 2015 RX No No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-005 Oct 1, 2004 DISCN No No   Start Trial   Start Trial Y   Start Trial
Emd Serono ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597-001 Dec 1, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
>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 somatropin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-008 Jan 27, 1998   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-003 Jun 20, 2000   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-003 Jan 27, 1998   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-002 Jun 20, 2000   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-010 Mar 1, 2010   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-009 Mar 1, 2010   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-009 Jan 27, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
AstraZeneca
McKesson
Harvard Business School
Medtronic

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