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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Cerilliant
US Department of Justice
Dow
Fish and Richardson
Chinese Patent Office
Express Scripts
Baxter

Generated: August 20, 2018

DrugPatentWatch Database Preview

NOVOLOG MIX 70/30 FLEXPEN Drug Profile

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When do Novolog Mix 70/30 Flexpen patents expire, and when can generic versions of Novolog Mix 70/30 Flexpen launch?

Novolog Mix 70/30 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 MIX 70/30 FLEXPEN is insulin aspart protamine recombinant; insulin aspart recombinant. 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 protamine recombinant; insulin aspart recombinant profile page.

Summary for NOVOLOG MIX 70/30 FLEXPEN
Drug patent expirations by year for NOVOLOG MIX 70/30 FLEXPEN
Generic Entry Opportunity Date for NOVOLOG MIX 70/30 FLEXPEN
Generic Entry Date for NOVOLOG MIX 70/30 FLEXPEN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;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 NOVOLOG MIX 70/30 FLEXPEN
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for NOVOLOG MIX 70/30 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 MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 MIX 70/30 FLEXPEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for NOVOLOG MIX 70/30 FLEXPEN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,235,004 Injection syringe ➤ Sign Up
6,582,404 Dose setting limiter ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NOVOLOG MIX 70/30 FLEXPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
91020-8 0090020-9 Sweden ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
2107069/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
2004005 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Julphar
Baxter
Citi
Harvard Business School
US Army
Fuji
QuintilesIMS
Cerilliant

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