Mozobil is a drug owned by Genzyme Corp. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Mozobil's patents have been open to challenges since 15 December, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 22, 2023. Details of Mozobil's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6987102 | Methods to mobilize progenitor/stem cells |
Jul, 2023
(1 year, 5 months ago) |
Expired
|
| US7897590 | Methods to mobilize progenitor/stem cells |
Jul, 2023
(1 year, 5 months ago) |
Expired
|
| USRE42152 | Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity |
Dec, 2018
(6 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 Mozobil's patents.
Latest Legal Activities on Mozobil's Patents
Given below is the list of recent legal activities going on the following patents of Mozobil.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Aug, 2022 | US7897590 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Aug, 2018 | US7897590 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Oct, 2014 | US6987102 (Litigated) |
| Email Notification Critical | 09 Oct, 2014 | US6987102 (Litigated) |
| Correspondence Address Change Critical | 08 Oct, 2014 | US6987102 (Litigated) |
| Email Notification Critical | 17 Jun, 2013 | US6987102 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 17 Jun, 2013 | US6987102 (Litigated) |
| Correspondence Address Change Critical | 14 Jun, 2013 | US6987102 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 15 May, 2013 | US7897590 (Litigated) |
| Correspondence Address Change Critical | 13 May, 2013 | US7897590 (Litigated) |
FDA has granted several exclusivities to Mozobil. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mozobil, 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 Mozobil.
Exclusivity Information
Mozobil holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Mozobil's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 15, 2013 |
| Orphan Drug Exclusivity(ODE) | Dec 15, 2015 |
Several oppositions have been filed on Mozobil'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 Mozobil's generic, the next section provides detailed information on ongoing and past EP oppositions related to Mozobil patents.
Mozobil's Oppositions Filed in EPO
Mozobil has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 26, 2012, by Generics [Uk] Limited. This opposition was filed on patent number EP02750370A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10184509A | May, 2020 | Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH | Granted and Under Opposition |
| EP10184509A | May, 2020 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP10184509A | May, 2020 | Sandoz AG | Granted and Under Opposition |
| EP10184509A | May, 2020 | Zentiva, k.s. | Granted and Under Opposition |
| EP10184509A | May, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP10184509A | May, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP10184509A | May, 2020 | Generics [UK] Limited (trading as Mylan) | Granted and Under Opposition |
| EP02750370A | Sep, 2012 | Actavis group PTC ehf | Revoked |
| EP02750370A | Sep, 2012 | Taylor Wessing LLP | Revoked |
| EP02750370A | Sep, 2012 | Generics [UK] Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Mozobil 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 Mozobil's family patents as well as insights into ongoing legal events on those patents.
Mozobil's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mozobil's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 22, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mozobil Generic API suppliers:
Plerixafor is the generic name for the brand Mozobil. 8 different companies have already filed for the generic of Mozobil, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mozobil's generic
How can I launch a generic of Mozobil before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mozobil's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mozobil'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 Mozobil -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 24 mg/1.2 mL vials (20 mg/mL) | 17 Dec, 2012 | 3 | 23 Jul, 2023 | Extinguished |
About Mozobil
Mozobil is a drug owned by Genzyme Corp. It is used for mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma and multiple myeloma for autologous transplantation. Mozobil uses Plerixafor as an active ingredient. Mozobil was launched by Genzyme in 2008.
Approval Date:
Mozobil was approved by FDA for market use on 15 December, 2008.
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 Mozobil is 15 December, 2008, its NCE-1 date is estimated to be 15 December, 2012.
Active Ingredient:
Mozobil uses Plerixafor as the active ingredient. Check out other Drugs and Companies using Plerixafor ingredient
Treatment:
Mozobil is used for mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma and multiple myeloma for autologous transplantation.
Dosage:
Mozobil is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 24MG/1.2ML (20MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |