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:

AstraZeneca
Express Scripts
Harvard Business School
Moodys
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Dow

Last Updated: December 5, 2019

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Novo Company Profile

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Summary for Novo
International Patents:626
US Patents:61
Tradenames:56
Ingredients:37
NDAs:46
Patent Litigation for Novo: See patent lawsuits for Novo

Drugs and US Patents for Novo

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No 9,616,180   Start Trial Y   Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes 10,220,155   Start Trial Y   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-011 Jan 23, 2015 RX No No 9,132,239   Start Trial Y   Start Trial
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 019721-001 May 8, 1995 DISCN No No   Start Trial   Start Trial
Novo TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No 8,579,869   Start Trial Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes 9,775,953   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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RE43834   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-006 Oct 1, 2004 6,235,004   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-001 Nov 1, 2001 5,866,538*PED   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-009 Mar 1, 2010 8,841,252   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-003 Nov 1, 2001 5,547,930   Start Trial
Novo Nordisk Inc VAGIFEM estradiol TABLET;VAGINAL 020908-002 Nov 25, 2009 5,860,946   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NOVO 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 Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 PA2009004,C0770388 Lithuania   Start Trial PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
1506211 122014000071 Germany   Start Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0944648 SPC034/2009 Ireland   Start Trial SPC034/2009: 20101001, EXPIRES: 20220821
2107069 C20130014 00133 Estonia   Start Trial PRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
1863839 2018C/016 Belgium   Start Trial PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Baxter
Harvard Business School
Boehringer Ingelheim
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.