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:

Mallinckrodt
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Colorcon
McKesson
Baxter
Dow

Last Updated: December 14, 2019

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NORDITROPIN Drug Profile

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When do Norditropin patents expire, and what generic alternatives are available?

Norditropin is a drug marketed by Novo Nordisk Inc and is included in two NDAs. There are twenty-two patents protecting this drug.

The generic ingredient in NORDITROPIN is somatropin. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the somatropin profile page.

US ANDA Litigation and Generic Entry Outlook for Norditropin

Norditropin was eligible for patent challenges on December 31st, 1968.

Drug patent expirations by year for NORDITROPIN
Drug Prices for NORDITROPIN

See drug prices for NORDITROPIN

Recent Clinical Trials for NORDITROPIN

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

SponsorPhase
Center for Human ReproductionPhase 1/Phase 2
Oregon Health and Science UniversityN/A
University of AarhusN/A

See all NORDITROPIN clinical trials

Recent Litigation for NORDITROPIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
SMITH v. NOVO NORDISK INC.2016-08-08
Illinois Tool Works Inc. v. Frito-Lay North America Inc.2006-01-27
Merck & Co. Inc. v. Dr. Reddy&039s Lab. Ltd2004-09-29

See all NORDITROPIN litigation

Pharmacology for NORDITROPIN

US Patents and Regulatory Information for NORDITROPIN

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 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 021148-009 Mar 1, 2010 BX RX No No   Start Trial   Start Trial Y   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 NORDITROPIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-002 Jun 20, 2000   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 019721-001 May 8, 1995   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-002 Jun 20, 2000   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-003 Jun 20, 2000   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:

Boehringer Ingelheim
McKesson
Harvard Business School
Mallinckrodt
Express Scripts
Baxter

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