RYZODEG 70 Drug Profile
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Note on Biologic Patents
Matching patents to biologic drugs is far more complicated than for small-molecule drugs.
DrugPatentWatch employs three methods to identify biologic patents:
- Brand-side disclosures in response to biosimilar applications
- DrugPatentWatch analysis and company disclosures
- Patents from broad patent text search
These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.
These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
1) High Certainty: US Patents for RYZODEG 70 Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for RYZODEG 70 Derived from DrugPatentWatch Analysis and Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2034-08-21 | DrugPatentWatch analysis and company disclosures |
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2037-12-14 | DrugPatentWatch analysis and company disclosures |
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2037-11-01 | DrugPatentWatch analysis and company disclosures |
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2037-12-21 | DrugPatentWatch analysis and company disclosures |
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2039-08-27 | DrugPatentWatch analysis and company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for RYZODEG 70 Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2039-06-21 | Patent claims search |
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2033-10-09 | Patent claims search |
| Novo Nordisk Inc. | RYZODEG 70/30 | insulin degludec and insulin aspart | Injection | 203313 | ⤷ Start Trial | 2032-10-25 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for RYZODEG 70
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 921812 | ⤷ Start Trial |
| Australia | 2006207744 | ⤷ Start Trial |
| Hungary | S1300033 | ⤷ Start Trial |
| South Korea | 100451778 | ⤷ Start Trial |
| South Africa | 200703707 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RYZODEG 70
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 300596 | Netherlands | ⤷ Start Trial | PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123 |
| 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 |
| C201300036 | Spain | ⤷ Start Trial | PRODUCT NAME: INSULINA DEGLUDEC/INSULINA ASPART; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001, 004, 005, 007, 008; DATE OF AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, 004, 005, 007, 008; DATE OF FIRST AUTHORISATION IN EEA: 20130121 |
| 122013000061 | Germany | ⤷ Start Trial | PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121 |
| C300596 | Netherlands | ⤷ Start Trial | PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
