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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Healthtrust
Baxter
Julphar
Fuji
Argus Health
QuintilesIMS
Federal Trade Commission
Accenture

Generated: August 20, 2018

DrugPatentWatch Database Preview

INSULIN ASPART RECOMBINANT - Generic Drug Details

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What are the generic sources for insulin aspart recombinant and what is the scope of insulin aspart recombinant patent protection?

Insulin aspart recombinant is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart recombinant has one hundred and seventy-three patent family members in twenty-two countries.

There are forty drug master file entries for insulin aspart recombinant. Three suppliers are listed for this compound.

Summary for INSULIN ASPART RECOMBINANT
Pharmacology for INSULIN ASPART RECOMBINANT
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for INSULIN ASPART RECOMBINANT

US Patents and Regulatory Information for INSULIN ASPART RECOMBINANT

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 FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG PENFILL insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-002 Jun 7, 2000 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No ➤ 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 INSULIN ASPART RECOMBINANT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-001 Jun 7, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG PENFILL insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-002 Jun 7, 2000 ➤ 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 INSULIN ASPART RECOMBINANT

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
6,582,404 Dose setting limiter ➤ Sign Up
6,235,004 Injection syringe ➤ Sign Up
8,357,120 Injection device with torsion spring and rotatable display ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for INSULIN ASPART RECOMBINANT

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:

Chubb
Chinese Patent Office
US Department of Justice
Deloitte
Mallinckrodt
US Army
Baxter
Cantor Fitzgerald
AstraZeneca

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.