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Insulin aspart recombinant - Generic Drug Details

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What are the generic drug sources for insulin aspart recombinant and what is the scope of insulin aspart recombinant patent protection?

Insulin aspart recombinant is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart recombinant has two hundred and twelve patent family members in twenty-two countries.

There are forty drug master file entries for insulin aspart recombinant. Six suppliers are listed for this compound.

Summary for insulin aspart recombinant

International Patents:	212
US Patents:	21
Tradenames:	5
Applicants:	1
NDAs:	1
Drug Master File Entries:	40
Suppliers / Packagers:	6
Clinical Trials:	373
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin aspart recombinant
DailyMed Link:	insulin aspart recombinant at DailyMed

Pharmacology for insulin aspart recombinant

Drug Class

Insulin Analog

Medical Subject Heading (MeSH) Categories for insulin aspart recombinant

Hypoglycemic Agents

US Patents and Regulatory Information for insulin aspart recombinant

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 PENFILL	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-002	Jun 7, 2000		RX	Yes	Yes			Y
Novo Nordisk Inc	NOVOLOG FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001		RX	Yes	Yes			Y
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013		DISCN	Yes	No			Y
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013		DISCN	Yes	No			Y
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013		DISCN	Yes	No			Y
Novo Nordisk Inc	NOVOLOG	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-001	Jun 7, 2000		RX	Yes	Yes
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013		DISCN	Yes	No			Y

Expired US Patents for insulin aspart recombinant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	NOVOLOG	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-001	Jun 7, 2000
Novo Nordisk Inc	NOVOLOG FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001
Novo Nordisk Inc	NOVOLOG FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001
Novo Nordisk Inc	NOVOLOG PENFILL	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-002	Jun 7, 2000
Novo Nordisk Inc	NOVOLOG PENFILL	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-002	Jun 7, 2000
Novo Nordisk Inc	NOVOLOG INNOLET	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-004	Apr 23, 2004
Novo Nordisk Inc	NOVOLOG FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001

International Patents for insulin aspart recombinant

Country	Patent Number	Estimated Expiration
Brazil	9906857
Canada	2616248
Poland	374182
Czech Republic	297361
Austria	483487
Australia	2008213084
China	1374876

Supplementary Protection Certificates for insulin aspart recombinant

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498802	300883	Netherlands		PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2107069	2013/034	Ireland		PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
0885961	SPC/GB05/024	United Kingdom		PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
0792290	0491022-0	Sweden		PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
0368187	C300019	Netherlands		PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
2107069	C 2013 019	Romania		PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2209800	1490067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918