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Last Updated: November 14, 2019

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Novo Nordisk Company Profile

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Summary for Novo Nordisk
International Patents:380
US Patents:33
Tradenames:44
Ingredients:29
NDAs:36
Patent Litigation for Novo Nordisk: See patent lawsuits for Novo Nordisk

Drugs and US Patents for Novo Nordisk

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 9,687,611   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No 8,920,383   Start Trial Y   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-009 Mar 1, 2010 BX RX No No RE46363   Start Trial Y   Start Trial
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005 DISCN No No 5,750,497   Start Trial Y Y   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-010 Mar 1, 2010 RX No No 9,616,180   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 Novo Nordisk

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-002 Jun 20, 2000 5,849,700   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-005 Oct 1, 2004 6,235,004   Start Trial
Novo Nordisk Inc PRANDIMET metformin hydrochloride; repaglinide TABLET;ORAL 022386-001 Jun 23, 2008 6,677,358   Start Trial
Novo Nordisk Inc NOVOLOG MIX 50/50 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021810-001 Aug 26, 2008 5,618,913*PED   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-005 Oct 1, 2004 6,004,297   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NOVO NORDISK drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 1 mg/500 mg and 2 mg/500 mg ➤ Subscribe 2009-04-09
➤ Subscribe Injection 18 mg/3 mL prefilled syringe ➤ Subscribe 2016-12-12
➤ Subscribe Vaginal Tablets 10 mcg ➤ Subscribe 2013-01-02

Supplementary Protection Certificates for Novo Nordisk Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 92213 Luxembourg   Start Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
1506211 179 5017-2014 Slovakia   Start Trial PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1412357 C 2008 016 Romania   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1261586 C300524 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
1532149 92128 Luxembourg   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Baxter
Colorcon
Boehringer Ingelheim
McKinsey

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