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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 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 thirty-nine 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:	39
Suppliers / Packagers:	3
Clinical Trials:	4,106
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		RX	Yes	Yes			Y
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013		RX	Yes	Yes			Y
Novo Nordisk Inc	NOVOLOG FLEXTOUCH	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-005	Oct 31, 2013		RX	Yes	Yes			Y
Novo Nordisk Inc	NOVOLOG FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001		RX	Yes	Yes			Y

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Expired US Patents for insulin aspart recombinant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	NOVOLOG FLEXPEN	insulin aspart recombinant	INJECTABLE;SUBCUTANEOUS	020986-003	Jan 19, 2001
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

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

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International Patents for insulin aspart recombinant

Country	Document Number	Estimated Expiration
Poland	196742
Czech Republic	297361
Denmark	1804865
Japan	4970282

Supplementary Protection Certificates for insulin aspart recombinant

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
213	Luxembourg		PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
2004005	Lithuania		PRODUCT NAME: INSULIN DETEMIR
0880	Netherlands		PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
/2005	Austria		PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005