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Insulin aspart recombinant - Generic Drug Details

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What are the generic sources for insulin aspart recombinant and what is the scope of insulin aspart recombinant freedom to operate?

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

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

Summary for insulin aspart recombinant

US Patents:	18
Tradenames:	5
Applicants:	1
NDAs:	1
Drug Master File Entries:	40
Suppliers / Packagers:	3
Clinical Trials:	347
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

Ingredient-type	Insulin
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 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 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 INNOLET	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-004	Apr 23, 2004
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

International Patents for insulin aspart recombinant

Country	Document Number	Estimated Expiration
Brazil	PI0919925
Russian Federation	2007126416
European Patent Office	1250167
Japan	2009050713

Supplementary Protection Certificates for insulin aspart recombinant

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2013000062	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
2004005	Lithuania		PRODUCT NAME: INSULIN DETEMIR
0885961/01	Switzerland		PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
0883	Netherlands		PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113