DrugPatentWatch Database Preview

Insulin aspart recombinant - Generic Drug Details

  Purchase this report

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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 sixteen 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. Three suppliers are listed for this compound.

Summary for insulin aspart recombinant

International Patents:	173
US Patents:	16
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 FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001		RX	Yes	Yes			Y

  Purchase this report

see a sample report or, see our see our flat-rate plans

Expired US Patents for insulin aspart recombinant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	NOVOLOG INNOLET	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-004	Apr 23, 2004
Novo Nordisk Inc	NOVOLOG	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-001	Jun 7, 2000
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013
Novo Nordisk Inc	NOVOLOG PENFILL	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-002	Jun 7, 2000

Non-Orange Book US Patents for insulin aspart recombinant

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,582,404	Dose setting limiter
6,235,004	Injection syringe
8,357,120	Injection device with torsion spring and rotatable display
7,686,786	Dial-down mechanism for wind-up pen

  Purchase this report

see a sample report or, see our see our flat-rate plans

International Patents for insulin aspart recombinant

Country	Document Number	Estimated Expiration
Russian Federation	2389514
Australia	2008213084
Austria	444090
World Intellectual Property Organization (WIPO)	0119434

Supplementary Protection Certificates for insulin aspart recombinant

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017 00020	Denmark		PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
34/2000	Austria		PRODUCT NAME: LANTUS - INSULIN GLARGIN
2017000039	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
2107069/01	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013