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Serving 500+ biopharmaceutical companies globally:

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Generated: July 24, 2017

DrugPatentWatch Database Preview

Insulin aspart protamine recombinant; insulin aspart recombinant - Generic Drug Details

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

Insulin aspart protamine recombinant; insulin aspart recombinant
is the generic ingredient in four branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart protamine recombinant; insulin aspart recombinant has ninety-eight patent family members in twenty-two countries.

There are thirty-eight drug master file entries for insulin aspart protamine recombinant; insulin aspart recombinant. Two suppliers are listed for this compound.

Summary for Generic Name: insulin aspart protamine recombinant; insulin aspart recombinant

Tradenames:4
Patents:5
Applicants:1
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packagers: see list2
Clinical Trials: see list5,423
Drug Prices:see low prices
DailyMed Link:insulin aspart protamine recombinant; insulin aspart recombinant at DailyMed

Pharmacology for Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
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;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG MIX 70/30
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-001Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin aspart protamine recombinant; 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► Subscribe
6,235,004 Injection syringe► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

Country Document Number Estimated Expiration
Hungary0202575► Subscribe
Japan3270761► Subscribe
Norway324430► Subscribe
Taiwan453884► Subscribe
Israel135255► 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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Supplementary Protection Certificates for Tradename: INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2004005,C0792290Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Accenture
Julphar
Novartis
Medtronic
Cantor Fitzgerald
AstraZeneca
McKinsey
Deloitte

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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