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Last Updated: January 19, 2020

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Somatropin recombinant - Generic Drug Details

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

Somatropin recombinant is the generic ingredient in six branded drugs marketed by Emergent, Lilly, Novo Nordisk Inc, Genentech, Lg Chem Ltd, and Emd Serono, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for somatropin recombinant

Identify potential brand extensions & 505(b)(2) entrants

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

See all somatropin recombinant clinical trials

Recent Litigation for somatropin recombinant

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08
Kyphon, Inc. v. Phan2007-08-21

See all somatropin recombinant litigation

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
Emd Serono ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597-001 Dec 1, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-005 Feb 4, 1999 BX RX Yes No   Start Trial   Start Trial   Start Trial
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-001 Jun 23, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-007 Feb 4, 1999 RX Yes Yes   Start Trial   Start Trial   Start Trial
Emd Serono ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597-002 Dec 1, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-006 Feb 4, 1999 RX Yes Yes   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 recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 019721-001 May 8, 1995   Start Trial   Start Trial
Genentech NUTROPIN DEPOT somatropin recombinant INJECTABLE;INJECTION 021075-002 Dec 22, 1999   Start Trial   Start Trial
Emd Serono ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597-004 Dec 1, 2003   Start Trial   Start Trial
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-004 Mar 8, 1987   Start Trial   Start Trial
Emd Serono ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597-004 Dec 1, 2003   Start Trial   Start Trial
Genentech NUTROPIN DEPOT somatropin recombinant INJECTABLE;INJECTION 021075-001 Dec 22, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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