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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 thirty patent family members on NOVO drugs in forty-three countries and one hundred and eighty supplementary protection certificates in nineteen 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	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	7,762,994*PED	Start Trial			Y	Start Trial
Novo	FIASP FLEXTOUCH	insulin aspart	SOLUTION;SUBCUTANEOUS	208751-002	Sep 29, 2017		RX	Yes	Yes	8,579,869	Start Trial	Y			Start Trial
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013		DISCN	Yes	No	9,457,154	Start Trial	Y			Start Trial
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	No	10,086,047	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	LEVEMIR FLEXTOUCH	insulin detemir recombinant	INJECTABLE;SUBCUTANEOUS	021536-005	Oct 31, 2013	5,866,538	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 FLEXPRO	somatropin	INJECTABLE;INJECTION	021148-010	Mar 1, 2010	5,849,700	Start Trial
Novo Nordisk Inc	NORDITROPIN	somatropin	INJECTABLE;INJECTION	021148-003	Jun 20, 2000	5,633,352	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CR 2014 00037	Denmark	Start Trial	PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1412357	C300357	Netherlands	Start Trial	PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1863839	C01863839/01	Switzerland	Start Trial	PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
2597103	2017/015	Ireland	Start Trial	PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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