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NOVOLOG FLEXTOUCH Drug Profile
When do Novolog Flextouch patents expire, and what generic alternatives are available?
Novolog Flextouch is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are eighteen patents protecting this drug.
This drug has one hundred and thirty-five patent family members in seventeen countries.
The generic ingredient in NOVOLOG FLEXTOUCH is insulin aspart recombinant. There are forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin aspart recombinant profile page.
Summary for NOVOLOG FLEXTOUCH
| International Patents: | 135 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NOVOLOG FLEXTOUCH |
| DailyMed Link: | NOVOLOG FLEXTOUCH at DailyMed |
Recent Litigation for NOVOLOG FLEXTOUCH
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| SMITH v. NOVO NORDISK INC. | 2016-08-08 |
Pharmacology for NOVOLOG FLEXTOUCH
| Drug Class | Insulin Analog |
US Patents and Regulatory Information for NOVOLOG FLEXTOUCH
| 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 | |||
| >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 NOVOLOG FLEXTOUCH
| 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 | Start Trial | Start Trial |
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NOVOLOG FLEXTOUCH
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 1843809 | Start Trial |
| Japan | 2013154219 | Start Trial |
| Russian Federation | 2318541 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NOVOLOG FLEXTOUCH
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2498802 | C201730022 | Spain | Start Trial | PRODUCT NAME: SULIQUA-INSULINA GLARGINA/ LIXISENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1157; DATE OF AUTHORISATION: 20170111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1157; DATE OF FIRST AUTHORISATION IN EEA: 20170111 |
| 2209800 | 14C0085 | France | Start Trial | PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
| 2597103 | CA 2017 00013 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
