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Serving leading biopharmaceutical companies globally:

McKesson
QuintilesIMS
Queensland Health
Novartis
Healthtrust
Express Scripts
Covington
Harvard Business School
Daiichi Sankyo
Boehringer Ingelheim

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for Patent: 5,866,538

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Which drugs does patent 5,866,538 protect, and when does it expire?


Patent 5,866,538 protects LEVEMIR, LEVEMIR FLEXPEN, LEVEMIR FLEXTOUCH, LEVEMIR INNOLET, LEVEMIR PENFILL, RYZODEG 70/30, NOVOLOG, NOVOLOG FLEXPEN, NOVOLOG FLEXTOUCH, NOVOLOG INNOLET, NOVOLOG MIX 50/50, NOVOLOG MIX 70/30, NOVOLOG MIX 70/30 FLEXPEN, NOVOLOG MIX 70/30 PENFILL, and NOVOLOG PENFILL, and is included in five NDAs.

Protection for NOVOLOG has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-eight patent family members in twenty countries.

Summary for Patent: 5,866,538

Title: Insulin preparations containing NaCl
Abstract:Insulin preparations of superior chemical stability, comprising human insulin or an analogue or derivative thereof, glycerol and/or mannitol, and 5 to 100 mM of a halogenide are disclosed.
Inventor(s): Norup; Elsebeth (Jyllinge, DK), Langkj.ae butted.r; Liselotte (Klampenborg, DK), Havelund; Svend (Bagsvaerd, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:08/879,991
Patent Claim Types:
see list of patent claims
Formulation; Compound;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Novo Nordisk IncLEVEMIRinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005RXYesYes► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncLEVEMIR FLEXTOUCHinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncLEVEMIR INNOLETinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-003Jun 16, 2005DISCNNoNo► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncLEVEMIR PENFILLinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005DISCNNoNo► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncRYZODEG 70/30insulin aspart; insulin degludecSOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncNOVOLOGinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-001Jun 7, 2000RXYesYes► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY
Novo Nordisk IncNOVOLOG INNOLETinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoNo► Subscribe► Subscribe► SubscribeY
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Foreign Priority and PCT Information for Patent: 5,866,538

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark685/96Jun 20, 1996

International Patent Family for Patent: 5,866,538

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria208208► Subscribe
Australia3253697► Subscribe
Australia720484► Subscribe
Brazil9709845► Subscribe
Canada2258097► Subscribe
China1120019► Subscribe
China1222083► Subscribe
Czech Republic297937► Subscribe
Czech Republic9803956► Subscribe
Germany69708121► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Chubb
Citi
Dow
Argus Health
Johnson and Johnson
Daiichi Sankyo
Teva
Colorcon
Boehringer Ingelheim
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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