Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

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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 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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Recent Clinical Trials for INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

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SponsorPhase
Vancouver General HospitalPhase 4
SanofiPhase 4
Novo Nordisk A/SPhase 4

See all INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT clinical trials

Recent Litigation for INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

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District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.2017-08-08
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08

See all INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT litigation

Pharmacology for INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
Drug ClassInsulin Analog

US Patents and Regulatory Information for INSULIN ASPART PROTAMINE RECOMBINANT; 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 MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-003 Nov 1, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-002 Nov 1, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG MIX 50/50 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021810-001 Aug 26, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for 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;SUBCUTANEOUS 021172-001 Nov 1, 2001   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-003 Nov 1, 2001   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2209800 SPC/GB14/079 United Kingdom   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922
2498802 2017030 Norway   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Harvard Business School
Dow
Baxter
Johnson and Johnson

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.