Ninlaro is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 9 US drug patents filed from 2015 to 2016. Out of these, 7 drug patents are active and 2 have expired. Ninlaro's patents have been open to challenges since 21 November, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 20, 2029. Details of Ninlaro'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. | |||
| US7442830 | Proteasome inhibitors |
Nov, 2029
(4 years from now) | Active |
| US8859504 | Boronate ester compounds and pharmaceutical compositions thereof |
Jun, 2029
(4 years from now) | Active |
| US7687662 | Proteasome inhibitors |
Aug, 2027
(2 years from now) | Active |
| US8003819 | Proteasome inhibitors |
Aug, 2027
(2 years from now) | Active |
| US8530694 | Proteasome inhibitors |
Aug, 2027
(2 years from now) | Active |
| US8546608 | Proteasome inhibitors and methods of using the same |
Aug, 2024
(4 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9175017 | Boronate ester compounds and pharmaceutical compositions thereof |
Jun, 2029
(4 years from now) | Active |
| US8871745 | Proteasome inhibitors |
Aug, 2027
(2 years from now) | Active |
| US9233115 | Proteasome inhibitors and methods of using the same |
Aug, 2024
(4 months 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 Ninlaro's patents.
Latest Legal Activities on Ninlaro's Patents
Given below is the list of recent legal activities going on the following patents of Ninlaro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jun, 2023 | US9233115 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9175017 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jan, 2023 | US8003819 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Mar, 2022 | US8871745 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Mar, 2022 | US8859504 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Sep, 2021 | US7687662 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Apr, 2021 | US8546608 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Mar, 2021 | US8530694 |
| Post Issue Communication - Certificate of Correction | 04 Jun, 2020 | US8871745 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Apr, 2020 | US7442830 |
FDA has granted several exclusivities to Ninlaro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ninlaro, 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 Ninlaro.
Exclusivity Information
Ninlaro holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Ninlaro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 20, 2020 |
| Orphan Drug Exclusivity(ODE) | Nov 20, 2022 |
| Orphan Drug Exclusivity(ODE-103) | Nov 20, 2022 |
Several oppositions have been filed on Ninlaro'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 Ninlaro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ninlaro patents.
Ninlaro's Oppositions Filed in EPO
Ninlaro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 04, 2010, by Millennium Pharmaceuticals, Inc.. This opposition was filed on patent number EP04786507A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13191414A | Jan, 2017 | Generics (U.K.) Limited (trading as Mylan) | Revoked |
| EP09767050A | Jan, 2016 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP09767050A | Jan, 2016 | Actavis PTC ehf | Granted and Under Opposition |
| EP09767050A | Jan, 2016 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP07811087A | Apr, 2013 | Cephalon, Inc. | Opposition procedure closed |
| EP04786507A | May, 2010 | Millennium Pharmaceuticals, Inc. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Ninlaro 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 Ninlaro's family patents as well as insights into ongoing legal events on those patents.
Ninlaro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ninlaro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 20, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ninlaro Generics:
There are no approved generic versions for Ninlaro as of now.
How can I launch a generic of Ninlaro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ninlaro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ninlaro's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ninlaro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.3 mg, 3 mg and 4 mg | 20 Nov, 2019 | 1 | 20 Nov, 2029 |
About Ninlaro
Ninlaro is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating multiple myeloma in patients who have received at least one prior therapy. Ninlaro uses Ixazomib Citrate as an active ingredient. Ninlaro was launched by Takeda Pharms Usa in 2015.
Can you believe Ninlaro received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Ninlaro was approved by FDA for market use on 20 November, 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 Ninlaro is 20 November, 2015, its NCE-1 date is estimated to be 21 November, 2019.
Active Ingredient:
Ninlaro uses Ixazomib Citrate as the active ingredient. Check out other Drugs and Companies using Ixazomib Citrate ingredient
Treatment:
Ninlaro is used for treating multiple myeloma in patients who have received at least one prior therapy.
Dosage:
Ninlaro is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 3MG BASE | CAPSULE | Prescription | ORAL |
| EQ 4MG BASE | CAPSULE | Prescription | ORAL |
| EQ 2.3MG BASE | CAPSULE | Prescription | ORAL |