Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 16, 2019

DrugPatentWatch Database Preview

NOVOLOG FLEXPEN Drug Profile

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Which patents cover Novolog Flexpen, and when can generic versions of Novolog Flexpen launch?

Novolog Flexpen is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred patent family members in twenty-two countries.

The generic ingredient in NOVOLOG FLEXPEN is insulin aspart recombinant. There are forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin aspart recombinant profile page.

Drug patent expirations by year for NOVOLOG FLEXPEN
Drug Prices for NOVOLOG FLEXPEN

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Recent Clinical Trials for NOVOLOG FLEXPEN

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SponsorPhase
University of Texas Southwestern Medical CenterPhase 4
Novo Nordisk A/SPhase 4

See all NOVOLOG FLEXPEN clinical trials

Recent Litigation for NOVOLOG FLEXPEN

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District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08
Novo Nordisk A/S v. Sanofi-Aventis2005-09-02

See all NOVOLOG FLEXPEN litigation

Pharmacology for NOVOLOG FLEXPEN
Drug ClassInsulin Analog
Synonyms for NOVOLOG FLEXPEN
1024611-56-0
116094-23-6
139532-40-4
D933668QVX
Fiasp
INA-X14
Insulin aspart
Insulin aspart [USAN:INN:BAN]
NN1218
Novolog Innolet
Novolog Penfill
NovoMix
UNII-D933668QVX

US Patents and Regulatory Information for NOVOLOG FLEXPEN

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 FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NOVOLOG FLEXPEN

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

Supplementary Protection Certificates for NOVOLOG FLEXPEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340033 2017C/024 Belgium   See Pricing PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
2107069 SPC/GB13/037 United Kingdom   See Pricing PRODUCT NAME: INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, COMPLEXES, OR SALTS THEREOF; REGISTERED: UK EU/1/12/807/001 20130123; UK EU/1/12/807/004 20130123; UK EU/1/12/807/005 20130123; UK EU/1/12/807/007 20130123; UK EU/1/12/807/008 20130123; UK EU/1/12/807/009 20130123; UK EU/1/12/807/012 20130123; UK EU/1/12/807/013 20130123; UK EU/1/12/807/015 20130123
2597103 CR 2017 00013 Denmark   See Pricing PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2107069 C02107069/01 Switzerland   See Pricing PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
2209800 122014000114 Germany   See Pricing PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
0792290 C300160 Netherlands   See Pricing PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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