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Insulin aspart recombinant - Generic Drug Details
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What are the generic drug sources for insulin aspart recombinant and what is the scope of 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 twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Insulin aspart recombinant has two hundred and thirteen patent family members in twenty-two countries.
There are forty drug master file entries for insulin aspart recombinant. Four suppliers are listed for this compound.
Summary for insulin aspart recombinant
| International Patents: | 213 |
| US Patents: | 23 |
| Tradenames: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 40 |
| Suppliers / Packagers: | 4 |
| Clinical Trials: | 376 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for insulin aspart recombinant |
| DailyMed Link: | insulin aspart recombinant at DailyMed |
Recent Clinical Trials for insulin aspart recombinant
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Institut de Recherches Cliniques de Montreal | Phase 2 |
| Nantes University Hospital | Phase 4 |
| University of Colorado, Denver | Phase 4 |
Recent Litigation for insulin aspart recombinant
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-03-03 |
| SMITH v. NOVO NORDISK INC. | 2016-08-08 |
| Basic Line, Inc. | 2010-01-20 |
Pharmacology for insulin aspart recombinant
| Drug Class | Insulin 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | NOVOLOG FLEXPEN | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-003 | Jan 19, 2001 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 recombinant
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | NOVOLOG FLEXPEN | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-003 | Jan 19, 2001 | Start Trial | Start Trial |
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | Start Trial | Start Trial |
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | Start Trial | Start Trial |
| Novo Nordisk Inc | NOVOLOG | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-001 | Jun 7, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for insulin aspart recombinant
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 60204422 | Start Trial |
| Denmark | 1536854 | Start Trial |
| South Korea | 20070084392 | Start Trial |
| Austria | 197408 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for insulin aspart recombinant
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2107069 | 2013C/035 | Belgium | Start Trial | PRODUCT NAME: TRESIBA-INSULINE DEGLUDEC; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001 20130121 |
| 2498802 | 2017/022 | Ireland | Start Trial | PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111 |
| 0368187 | 34/2000 | Austria | Start Trial | PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609 |
| 0792290 | 0491022-0 | Sweden | Start Trial | PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
ISSN: 2162-2639
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