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

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Last Updated: October 20, 2019

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Somatropin - Generic Drug Details

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What are the generic sources for somatropin and what is the scope of freedom to operate?

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-one 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
Ache Laboratorios Farmaceuticos S.A.Phase 4
The University of Texas Medical Branch, GalvestonPhase 3

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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
Ferring ZOMACTON somatropin INJECTABLE;INJECTION 019774-002 Jan 4, 2002 BX RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-011 Jan 27, 1998 RX Yes No   Start Trial   Start Trial   Start Trial
Genentech NUTROPIN AQ NUSPIN somatropin INJECTABLE;INJECTION 020522-005 Jan 3, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Emd Serono SAIZEN somatropin INJECTABLE;INJECTION 019764-002 Oct 8, 1996 BX RX Yes No   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-009 Mar 1, 2010 BX RX No No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-006 Oct 1, 2004 DISCN No No   Start Trial   Start Trial Y   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 020280-013 Jan 27, 1998   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-005 Jan 27, 1998   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-012 Jan 27, 1998   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-001 Jan 27, 1998   Start Trial   Start Trial
Pharmacia And Upjohn GENOTROPIN PRESERVATIVE FREE somatropin INJECTABLE;INJECTION 020280-008 Jan 27, 1998   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-010 Mar 1, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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