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Teva
US Army
Merck
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Fuji
Medtronic
McKinsey
Cipla
QuintilesIMS

Generated: December 17, 2018

DrugPatentWatch Database Preview

TRESIBA Drug Profile

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Which patents cover Tresiba, and what generic alternatives are available?

Tresiba is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and thirty-five patent family members in twenty-three countries.

The generic ingredient in TRESIBA is insulin degludec. There are forty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin degludec profile page.

Drug patent expirations by year for TRESIBA
Generic Entry Opportunity Date for TRESIBA
Generic Entry Date for TRESIBA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TRESIBA
Drug ClassInsulin Analog

US Patents and Regulatory Information for TRESIBA

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 TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 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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Supplementary Protection Certificates for TRESIBA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB00/022 United Kingdom ➤ Try a Free 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
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
0880 Netherlands ➤ Try a Free Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
90067-4 Sweden ➤ Try a Free Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2107069/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
34/2000 Austria ➤ Try a Free Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Army
Merck
Federal Trade Commission
Fuji
Medtronic
McKinsey
Cipla
QuintilesIMS

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