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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 eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart recombinant has one hundred and seventy-three patent family members in twenty-two countries.

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

Summary for insulin aspart recombinant

International Patents:	173
US Patents:	18
Tradenames:	5
Applicants:	1
NDAs:	1
Drug Master File Entries:	40
Suppliers / Packagers:	4
Clinical Trials:	361
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 INNOLET	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-004	Apr 23, 2004		DISCN	No	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 PENFILL	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-002	Jun 7, 2000
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013
Novo Nordisk Inc	NOVOLOG	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-001	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

International Patents for insulin aspart recombinant

Country	Document Number	Estimated Expiration
Brazil	PI0606607
World Intellectual Property Organization (WIPO)	2006076921
Germany	60043595
China	101605569
Japan	5185620

Supplementary Protection Certificates for insulin aspart recombinant

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00596	Netherlands		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
2107069/01	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
C/GB04/036	United Kingdom		PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
213	Luxembourg		PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
2017020,C2498802	Lithuania		PRODUCT NAME: INSULINAS GLARGINAS + LIKSISENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111