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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
UBS
Cantor Fitzgerald
Queensland Health
Fish and Richardson
Express Scripts
Deloitte
Moodys

Generated: September 21, 2018

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Novo Nordisk Inc Company Profile

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What is the competitive landscape for NOVO NORDISK INC, and when can generic versions of NOVO NORDISK INC drugs launch?

NOVO NORDISK INC has forty-one approved drugs.

There are thirty-four US patents protecting NOVO NORDISK INC drugs.

Summary for Novo Nordisk Inc

Drugs and US Patents for Novo Nordisk Inc

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 LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No 5,750,497 ➤ Sign Up Y Y ➤ Sign Up
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes 9,616,180 ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-005 Oct 1, 2004 DISCN No No 6,004,297 ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes RE43834 ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc ULTRALENTE insulin zinc susp extended purified beef INJECTABLE;INJECTION 018385-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Novo Nordisk Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-003 Nov 1, 2001 5,618,913*PED ➤ Sign Up
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 021148-003 Jun 20, 2000 5,849,704 ➤ Sign Up
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin recombinant INJECTABLE;INJECTION 021148-009 Mar 1, 2010 5,849,700 ➤ Sign Up
Novo Nordisk Inc NOVOLOG INNOLET insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-004 Apr 23, 2004 5,618,913*PED ➤ Sign Up
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin recombinant INJECTABLE;INJECTION 021148-009 Mar 1, 2010 8,841,252 ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-002 Nov 1, 2001 5,618,913*PED ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NOVO NORDISK INC 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

Non-Orange Book US Patents for Novo Nordisk Inc

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,011,007 Acylated insulin ➤ Sign Up
7,226,990 Extendin derivatives ➤ Sign Up
6,458,924 Derivatives of GLP-1 analogs ➤ Sign Up
8,357,120 Injection device with torsion spring and rotatable display ➤ Sign Up
6,384,016 Stabilized aqueous peptide solutions ➤ Sign Up
8,137,325 Needle mounting system and a method for mounting a needle assembly ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Novo Nordisk Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0085 France ➤ Sign Up PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2006 00038 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0883 Netherlands ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
/2004 Austria ➤ Sign Up PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
C0005 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2008013,C1412357 Lithuania ➤ Sign Up PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Mallinckrodt
Harvard Business School
Boehringer Ingelheim
Fuji
Accenture
Johnson and Johnson
Queensland Health
Covington

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