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Novo Company Profile

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

NOVO has forty-five approved drugs.

There are thirty-six US patents protecting NOVO drugs.

There are five hundred and forty-one patent family members on NOVO drugs in thirty-seven countries and one hundred and fifty-four supplementary protection certificates in seventeen countries.

Summary for Novo

International Patents:	541
US Patents:	36
Tradenames:	54
Ingredients:	36
NDAs:	45
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 Nordisk Inc	NOVOLOG MIX 70/30 PENFILL	insulin aspart protamine recombinant; insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	021172-003	Nov 1, 2001		DISCN	No	No
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	8,114,833		Y
Novo Nordisk Inc	NORDITROPIN NORDIFLEX	somatropin recombinant	INJECTABLE;INJECTION	021148-004	Oct 1, 2004		DISCN	No	No	6,235,004		Y
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	9,687,611		Y
Novo Nordisk Inc	ULTRALENTE	insulin zinc susp extended purified beef	INJECTABLE;INJECTION	018385-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Novo

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	NORDITROPIN	somatropin recombinant	INJECTABLE;INJECTION	021148-002	Jun 20, 2000	5,849,704
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013	5,866,538*PED
Novo Nordisk Inc	NOVOLOG	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-001	Jun 7, 2000	5,618,913*PED
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
Novo Nordisk Inc	NOVOLOG MIX 70/30 PENFILL	insulin aspart protamine recombinant; insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	021172-002	Nov 1, 2001	5,866,538*PED

Paragraph IV (Patent) Challenges for NOVO drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	1 mg/500 mg and 2 mg/500 mg		2009-04-09
	Injection	18 mg/3 mL prefilled syringe		2016-12-12
	Vaginal Tablets	10 mcg		2013-01-02

International Patents for Novo Drugs

Country	Patent Number	Estimated Expiration
South Korea	20030007889
Poland	363081
Japan	4361236
Japan	2006348038
Australia	2006207744

Supplementary Protection Certificates for Novo Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2107069	C300597	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
2498802	122017000039	Germany		PRODUCT NAME: SULIQUA (FIRMENEIGENER NAME DES MEDIZINISCHEN PRODUKTS) BZW. WIRKSTOFFZUSAMMENSETZUNG UMFASSEND INSULIN GLARGIN / LIXISENATID UND IHRE PHARMAZEUTISCH ANNEHMBAREN SALZE (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/16/1157 20170111
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
2209800	1490067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
0944648	SPC/GB09/058	United Kingdom		PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630

Similar Applicant Names

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

• Novo
• Novo Nordisk
• Novo Nordisk Inc
• Novocol Healthcare
• Novocol Inc