Ryzodeg 70/30 Patent Expiration

Ryzodeg 70/30 is a drug owned by Novo Nordisk Inc. It is protected by 22 US drug patents filed from 2015 to 2019. Out of these, 16 drug patents are active and 6 have expired. Ryzodeg 70/30's patents have been open to challenges since 26 September, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be May 01, 2033. Details of Ryzodeg 70/30's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7615532 Insulin derivatives
Jun, 2029

(4 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9884094 Method of treating diabetes mellitus
May, 2033

(8 years from now)

Active
US9132239 Dial-down mechanism for wind-up pen
Feb, 2032

(7 years from now)

Active
US9457154 Injection device with an end of dose feedback mechanism
Sep, 2027

(2 years from now)

Active
US9687611 Injection device with torsion spring and rotatable display
Feb, 2027

(2 years from now)

Active
US7686786 Dial-down mechanism for wind-up pen
Aug, 2026

(1 year, 7 months from now)

Active
USRE46363 Dial-down mechanism for wind-up pen
Aug, 2026

(1 year, 7 months from now)

Active
US9775953 Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Jul, 2026

(1 year, 7 months from now)

Active
US8920383 Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Jul, 2026

(1 year, 7 months from now)

Active
US10220155 Syringe device with a dose limiting mechanism and an additional safety mechanism
Jul, 2026

(1 year, 7 months from now)

Active
US9108002 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US10376652 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US10357616 Injection device with an end of dose feedback mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US9616180 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US9861757 Injection device with an end of dose feedback mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US8684969 Injection device with torsion spring and rotatable display
Oct, 2025

(10 months from now)

Active
US7762994 Needle mounting system and a method for mounting a needle assembly
May, 2024

(6 months ago)

Expired
US8579869 Needle mounting system and a method for mounting a needle assembly
Jun, 2023

(1 year, 5 months ago)

Expired
US8672898 Automatic injection device with reset feature
Jan, 2022

(2 years ago)

Expired
US6899699 Automatic injection device with reset feature
Jan, 2022

(2 years ago)

Expired
US9486588 Automatic injection device with reset feature
Jan, 2022

(2 years ago)

Expired
US5866538 Insulin preparations containing NaCl
Jun, 2017

(7 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ryzodeg 70/30's patents.

Given below is the list of recent legal activities going on the following patents of Ryzodeg 70/30.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 20 Jul, 2021 US9884094
Payment of Maintenance Fee, 12th Year, Large Entity 21 Apr, 2021 US7615532
Patent Term Extension Certificate 11 Sep, 2018 US7615532
Notice of Final Determination -Eligible 14 Mar, 2018 US7615532
Patent Issue Date Used in PTA Calculation 06 Feb, 2018 US9884094
Recordation of Patent Grant Mailed 06 Feb, 2018 US9884094
Email Notification 18 Jan, 2018 US9884094
Issue Notification Mailed 17 Jan, 2018 US9884094
Dispatch to FDC 23 Dec, 2017 US9884094
Reverse Issue Fee 21 Dec, 2017 US9884094


FDA has granted several exclusivities to Ryzodeg 70/30. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ryzodeg 70/30, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ryzodeg 70/30.

Exclusivity Information

Ryzodeg 70/30 holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Ryzodeg 70/30's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Dec 16, 2019
New Chemical Entity Exclusivity(NCE) Sep 25, 2020

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

Several oppositions have been filed on Ryzodeg 70/30's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Ryzodeg 70/30's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ryzodeg 70/30 patents.

Ryzodeg 70/30's Oppositions Filed in EPO

Ryzodeg 70/30 has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 23, 2006, by Owen Mumford Limited. This opposition was filed on patent number EP02726984A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP02726984A NA Genentech, Inc. Patent maintained as amended
EP06701034A Jan, 2018 Schwöbel, Thilo Opposition rejected
EP06754730A Dec, 2011 Ypsomed AG Patent maintained as amended
EP06754730A Nov, 2011 WMC Matthes Consulting Patent maintained as amended
EP06762643A Jul, 2010 Sanofi-Aventis Deutschland GmbH Patent maintained as amended
EP05796880A Jul, 2010 Stöckeler, Ferdinand Granted and Under Opposition
EP05796880A Jul, 2010 Ypsomed AG Granted and Under Opposition
EP05796880A Jul, 2010 Ferring International Center S.A. Granted and Under Opposition
EP05796880A Jul, 2010 OWEN MUMFORD LIMITED Granted and Under Opposition
EP05796880A Jul, 2010 Genentech, Inc. Granted and Under Opposition
EP05796880A Jul, 2010 COPERNICUS sp. zo.o. Granted and Under Opposition
EP06121820A May, 2010 SANOFI-AVENTIS DEUTSCHLAND GMBH Opposition rejected
EP02726984A Mar, 2006 TecPharma Licensing AG Patent maintained as amended
EP02726984A Feb, 2006 OWEN MUMFORD LIMITED Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Ryzodeg 70/30 is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ryzodeg 70/30's family patents as well as insights into ongoing legal events on those patents.

Ryzodeg 70/30's Family Patents

Ryzodeg 70/30 has patent protection in a total of 16 countries. It's US patent count contributes only to 28.9% of its total global patent coverage. Click below to unlock the full patent family tree for Ryzodeg 70/30.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Ryzodeg 70/30's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 01, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Ryzodeg 70/30 Generics:

There are no approved generic versions for Ryzodeg 70/30 as of now.





About Ryzodeg 70/30

Ryzodeg 70/30 is a drug owned by Novo Nordisk Inc. It is used for managing glycemic control in patients with diabetes mellitus. Ryzodeg 70/30 uses Insulin Aspart; Insulin Degludec as an active ingredient. Ryzodeg 70/30 was launched by Novo in 2015.

Approval Date:

Ryzodeg 70/30 was approved by FDA for market use on 25 September, 2015.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Ryzodeg 70/30 is 25 September, 2015, its NCE-1 date is estimated to be 26 September, 2019.

Active Ingredient:

Ryzodeg 70/30 uses Insulin Aspart; Insulin Degludec as the active ingredient. Check out other Drugs and Companies using Insulin Aspart; Insulin Degludec ingredient

Treatment:

Ryzodeg 70/30 is used for managing glycemic control in patients with diabetes mellitus.

Dosage:

Ryzodeg 70/30 is available in solution form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) SOLUTION Discontinued SUBCUTANEOUS