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Novo Company Profile

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NOVO has forty-six approved drugs.

There are sixty-one US patents protecting NOVO drugs.

There are six hundred and twenty-eight patent family members on NOVO drugs in forty-three countries and one hundred and sixty-six supplementary protection certificates in eighteen countries.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	TRESIBA	insulin degludec	SOLUTION;SUBCUTANEOUS	203314-002	Sep 25, 2015		RX	Yes	Yes	10,357,616	Start Trial	Y			Start Trial
Novo	RYZODEG 70/30	insulin aspart; insulin degludec	SOLUTION;SUBCUTANEOUS	203313-001	Sep 25, 2015		DISCN	Yes	No		Start Trial				Start Trial
Novo	TRESIBA	insulin degludec	SOLUTION;SUBCUTANEOUS	203314-001	Sep 25, 2015		RX	Yes	No	10,376,652	Start Trial	Y			Start Trial
Novo Nordisk Inc	NORDITROPIN FLEXPRO	somatropin	INJECTABLE;INJECTION	021148-010	Mar 1, 2010		RX	No	No	9,108,002	Start Trial	Y			Start Trial
Novo	XULTOPHY 100/3.6	insulin degludec; liraglutide	SOLUTION;SUBCUTANEOUS	208583-001	Nov 21, 2016		RX	Yes	Yes	9,108,002	Start Trial	Y			Start Trial
Novo Nordisk Inc	NORDITROPIN FLEXPRO	somatropin	INJECTABLE;INJECTION	021148-011	Jan 23, 2015		RX	No	No	9,486,588	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	NOVOLOG FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001	5,866,538*PED	Start Trial
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	6,458,924	Start Trial
Novo Nordisk Inc	NOVOLOG MIX 70/30	insulin aspart protamine recombinant; insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	021172-001	Nov 1, 2001	5,948,751	Start Trial
Novo Nordisk Inc	NOVOLOG PENFILL	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-002	Jun 7, 2000	5,693,027*PED	Start Trial
Novo Nordisk Inc	PRANDIMET	metformin hydrochloride; repaglinide	TABLET;ORAL	022386-002	Jun 23, 2008	6,677,358	Start Trial
Novo Nordisk Inc	NOVOLOG MIX 70/30	insulin aspart protamine recombinant; insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	021172-001	Nov 1, 2001	5,618,913*PED	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Vaginal Tablets	10 mcg	➤ Subscribe	2013-01-02
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368187	0091020-8 0090020-9	Sweden	Start Trial	PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
2107069	C300596	Netherlands	Start Trial	PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
1453521	93156	Luxembourg	Start Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1863839	2018C/016	Belgium	Start Trial	PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
2107069	300596	Netherlands	Start Trial	PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
1506211	92496	Luxembourg	Start Trial	PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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