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Last Updated: January 23, 2020

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FIASP FLEXTOUCH Drug Profile

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When do Fiasp Flextouch patents expire, and what generic alternatives are available?

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

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

The generic ingredient in FIASP FLEXTOUCH 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.

US ANDA Litigation and Generic Entry Outlook for Fiasp Flextouch

Fiasp Flextouch was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

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Drug patent expirations by year for FIASP FLEXTOUCH
Recent Clinical Trials for FIASP FLEXTOUCH

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novo Nordisk A/SN/A

See all FIASP FLEXTOUCH clinical trials

Recent Litigation for FIASP FLEXTOUCH

Identify potential future generic entrants

District Court Litigation
Case NameDate
SMITH v. NOVO NORDISK INC.2016-08-08

See all FIASP FLEXTOUCH litigation

Pharmacology for FIASP FLEXTOUCH
Drug ClassInsulin Analog

US Patents and Regulatory Information for FIASP FLEXTOUCH

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 FLEXTOUCH

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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
0368187 SPC/GB00/022 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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