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Generated: March 24, 2019

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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 four patents protecting this drug.

This drug has seventy-seven 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
Pharmacology for NOVOLOG FLEXPEN
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for NOVOLOG FLEXPEN
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Supplementary Protection Certificates for NOVOLOG FLEXPEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 300596 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
2498802 2017030 Norway ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
0885961 SZ 2/2005 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN GLULISINE
0792290 28/2004 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
2107069 C201300035 Spain ➤ Try a Free Trial PRODUCT NAME: INSULINA DEGLUDEC; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001, 004, 005, 007-009, 012, 013, 015; DATE OF AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001, 004, 005, 007-009, 012, 013, 015; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2498802 CR 2017 00020 Denmark ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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