DrugPatentWatch Database Preview
NOVOLOG FLEXTOUCH Drug Profile
When do Novolog Flextouch patents expire, and what generic alternatives are available?
This drug has ninety-six patent family members in seventeen countries.
The generic ingredient in NOVOLOG FLEXTOUCH is insulin aspart recombinant. There are thirty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the insulin aspart recombinant profile page.
Summary for NOVOLOG FLEXTOUCH
| International Patents: | 96 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Clinical Trials: | 29 |
| Drug Prices: | see details |
| DailyMed Link: | NOVOLOG FLEXTOUCH at DailyMed |
Pharmacology for NOVOLOG FLEXTOUCH
| Ingredient-type | Insulin |
| Drug Class | Insulin Analog |
Medical Subject Heading (MeSH) Categories for NOVOLOG FLEXTOUCH
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 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 | ➤ Sign Up | ➤ Sign Up |
| Novo Nordisk Inc | NOVOLOG FLEXTOUCH | insulin aspart recombinant | INJECTABLE;SUBCUTANEOUS | 020986-005 | Oct 31, 2013 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for NOVOLOG FLEXTOUCH
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 |
|---|---|---|
| 9,616,180 | Automatic injection device with a top release mechanism | ➤ Sign Up |
| 9,861,757 | Injection device with an end of dose feedback mechanism | ➤ Sign Up |
| 8,357,120 | Injection device with torsion spring and rotatable display | ➤ Sign Up |
| 7,686,786 | Dial-down mechanism for wind-up pen | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for NOVOLOG FLEXTOUCH
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2006079481 | ➤ Sign Up |
| Canada | 2584760 | ➤ Sign Up |
| Spain | 2243721 | ➤ Sign Up |
| China | 101107032 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for NOVOLOG FLEXTOUCH
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2004005,C0792290 | Lithuania | ➤ Sign Up | PRODUCT 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 |
| 2013000062 | Germany | ➤ Sign Up | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121 |
| C0020 | France | ➤ Sign Up | PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110 |
| C0035 | France | ➤ Sign Up | PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
