Xultophy 100/3.6 is a drug owned by Novo Nordisk Inc. It is protected by 45 US drug patents filed from 2016 to 2019. Out of these, 30 drug patents are active and 15 have expired. Xultophy 100/3.6'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 Aug 01, 2032. Details of Xultophy 100/3.6'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 |
| US6268343 | Derivatives of GLP-1 analogs |
Aug, 2022
(2 years ago) |
Expired
|
| US8846618 | Stable formulation of modified GLP-1 |
Jun, 2022
(2 years ago) |
Expired
|
| US7235627 | Derivatives of GLP-1 analogs |
Aug, 2017
(7 years ago) |
Expired
|
| US6458924 | Derivatives of GLP-1 analogs |
Aug, 2017
(7 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9132239 (Pediatric) | Dial-down mechanism for wind-up pen |
Aug, 2032
(7 years from now) | Active |
| US9132239 | Dial-down mechanism for wind-up pen |
Feb, 2032
(7 years from now) | Active |
|
US7615532 (Pediatric) | Insulin derivatives |
Dec, 2029
(5 years from now) | Active |
|
US8937042 (Pediatric) | Pharmaceutical compositions comprising GLP-1 peptides or extendin-4 and a basal insulin peptide |
Nov, 2029
(4 years from now) | Active |
| US8937042 | Pharmaceutical compositions comprising GLP-1 peptides or extendin-4 and a basal insulin peptide |
May, 2029
(4 years from now) | Active |
|
US9457154 (Pediatric) | Injection device with an end of dose feedback mechanism |
Mar, 2028
(3 years from now) | Active |
| US9457154 | Injection device with an end of dose feedback mechanism |
Sep, 2027
(2 years from now) | Active |
|
US9687611 (Pediatric) | Injection device with torsion spring and rotatable display |
Aug, 2027
(2 years from now) | Active |
| US9687611 | Injection device with torsion spring and rotatable display |
Feb, 2027
(2 years from now) | Active |
|
USRE46363 (Pediatric) | Dial-down mechanism for wind-up pen |
Feb, 2027
(2 years from now) | Active |
|
US9775953 (Pediatric) | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jan, 2027
(2 years from now) | Active |
|
US8920383 (Pediatric) | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jan, 2027
(2 years from now) | Active |
|
US10220155 (Pediatric) | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jan, 2027
(2 years from now) | Active |
| US7686786 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 8 months from now) | Active |
| USRE46363 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 8 months from now) | Active |
|
US9861757 (Pediatric) | Injection device with an end of dose feedback mechanism |
Jul, 2026
(1 year, 8 months from now) | Active |
|
US9108002 (Pediatric) | Automatic injection device with a top release mechanism |
Jul, 2026
(1 year, 8 months from now) | Active |
|
US9616180 (Pediatric) | Automatic injection device with a top release mechanism |
Jul, 2026
(1 year, 8 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 |
| 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 |
| 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 |
|
US8684969 (Pediatric) | Injection device with torsion spring and rotatable display |
Apr, 2026
(1 year, 5 months from now) | Active |
| US9861757 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US10376652 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US9108002 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US10357616 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US9616180 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US8684969 | Injection device with torsion spring and rotatable display |
Oct, 2025
(11 months from now) | Active |
|
US7762994 (Pediatric) | Needle mounting system and a method for mounting a needle assembly |
Nov, 2024
(7 days from now) | Active |
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(5 months ago) |
Expired
|
|
US8579869 (Pediatric) | Needle mounting system and a method for mounting a needle assembly |
Dec, 2023
(10 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(1 year, 4 months ago) |
Expired
|
|
US6268343 (Pediatric) | Derivatives of GLP-1 analogs |
Feb, 2023
(1 year, 8 months ago) |
Expired
|
|
US8846618 (Pediatric) | Stable formulation of modified GLP-1 |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
|
US8672898 (Pediatric) | Automatic injection device with reset feature |
Jul, 2022
(2 years ago) |
Expired
|
|
US9486588 (Pediatric) | Automatic injection device with reset feature |
Jul, 2022
(2 years ago) |
Expired
|
|
US6899699 (Pediatric) | Automatic injection device with reset feature |
Jul, 2022
(2 years ago) |
Expired
|
| US9486588 | Automatic injection device with reset feature |
Jan, 2022
(2 years 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
|
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 Xultophy 100/3.6's patents.
Latest Legal Activities on Xultophy 100/3.6's Patents
Given below is the list of recent legal activities going on the following patents of Xultophy 100/3.6.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Feb, 2022 | US8846618 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Apr, 2021 | US7615532 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Oct, 2018 | US7235627 |
| Patent Term Extension Certificate Critical | 11 Sep, 2018 | US7615532 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Mar, 2018 | US8846618 |
| Notice of Final Determination -Eligible | 14 Mar, 2018 | US7615532 |
| FDA Final Eligibility Letter Critical | 20 Sep, 2017 | US7615532 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 18 Apr, 2017 | US7615532 |
| Terminal Disclaimer Filed Critical | 14 Apr, 2017 | US7615532 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 13 Apr, 2017 | US7615532 |
FDA has granted several exclusivities to Xultophy 100/3.6. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xultophy 100/3.6, 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 Xultophy 100/3.6.
Exclusivity Information
Xultophy 100/3.6 holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Xultophy 100/3.6's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Nov 21, 2019 |
| New Chemical Entity Exclusivity(NCE) | Sep 25, 2020 |
| M(M-242) | Aug 08, 2022 |
Several oppositions have been filed on Xultophy 100/3.6'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 Xultophy 100/3.6's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xultophy 100/3.6 patents.
Xultophy 100/3.6's Oppositions Filed in EPO
Xultophy 100/3.6 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 |
|---|---|---|---|
 | |||
| 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 |
| EP02745182A | Sep, 2008 | AMYLIN PHARMACEUTICALS, INC. | 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 Xultophy 100/3.6 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 Xultophy 100/3.6's family patents as well as insights into ongoing legal events on those patents.
Xultophy 100/3.6's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xultophy 100/3.6's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xultophy 100/3.6 Generics:
There are no approved generic versions for Xultophy 100/3.6 as of now.
About Xultophy 100/3.6
Xultophy 100/3.6 is a drug owned by Novo Nordisk Inc. Xultophy 100/3.6 uses Insulin Degludec; Liraglutide as an active ingredient. Xultophy 100/3.6 was launched by Novo in 2016.
Approval Date:
Xultophy 100/3.6 was approved by FDA for market use on 21 November, 2016.
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 Xultophy 100/3.6 is 21 November, 2016, its NCE-1 date is estimated to be 26 September, 2019.
Active Ingredient:
Xultophy 100/3.6 uses Insulin Degludec; Liraglutide as the active ingredient. Check out other Drugs and Companies using Insulin Degludec; Liraglutide ingredient
Dosage:
Xultophy 100/3.6 is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |