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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Moodys
Mallinckrodt
McKesson
Baxter

Last Updated: December 5, 2019

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FIASP Drug Profile

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When do Fiasp patents expire, and when can generic versions of Fiasp launch?

Fiasp is a drug marketed by Novo and is included in one NDA. There are nineteen patents protecting this drug.

This drug has thirty patent family members in eighteen countries.

The generic ingredient in FIASP is insulin aspart. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin aspart profile page.

Summary for FIASP
Drug patent expirations by year for FIASP
Drug Prices for FIASP

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

US Patents and Regulatory Information for FIASP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo FIASP insulin aspart SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208751-001 Sep 29, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for FIASP

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 PA2017020,C2498802 Lithuania   Start Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSISENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
2209800 14C0085 France   Start Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2597103 CA 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
0368187 0091020-8 0090020-9 Sweden   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
2107069 SPC/GB13/037 United Kingdom   Start Trial 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
0792290 PA2004005 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR
2107069 13C0035 France   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Boehringer Ingelheim
Baxter
Harvard Business School
Medtronic

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