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NOVOLOG FLEXTOUCH Drug Profile
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» See Plans and PricingWhich patents cover Novolog Flextouch, and when can generic versions of Novolog Flextouch launch?
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-nine 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.
US ANDA Litigation and Generic Entry Outlook for Novolog Flextouch
Novolog Flextouch was eligible for patent challenges on June 7, 2004.
Indicators of Generic Entry
Summary for NOVOLOG FLEXTOUCH
| International Patents: | 139 |
| 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 | |||
| 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 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 |
|---|---|---|
| Japan | 3389045 | Start Trial |
| Russian Federation | 2007114761 | Start Trial |
| Denmark | 1003581 | Start Trial |
| Spain | 2689536 | Start Trial |
| Austria | 439883 | Start Trial |
| Israel | 135255 | Start Trial |
| Japan | 2662390 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NOVOLOG FLEXTOUCH
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2209800 | C300698 | Netherlands | Start Trial | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 |
| 2340033 | 300880 | Netherlands | Start Trial | PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109 |
| 0885961 | SZ 2/2005 | Austria | Start Trial | PRODUCT NAME: INSULIN GLULISINE |
| 2107069 | 13C0035 | France | Start Trial | PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121 |
| 2209800 | 14C0085 | France | Start Trial | PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
| 2107069 | 2013C/035 | Belgium | Start Trial | PRODUCT NAME: TRESIBA-INSULINE DEGLUDEC; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001 20130121 |
| 2107069 | 2013/34 | Ireland | Start Trial | PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
