Noxafil is a drug owned by Merck Sharp And Dohme Corp. It is protected by 8 US drug patents filed from 2013 to 2018. Out of these, 6 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 27, 2033. Details of Noxafil'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. | |||
| US5661151 | Tetrahydrofuran antifungals |
Jul, 2019
(6 years ago) |
Expired
|
| US5703079 | Tetrahydrofuran antifungals |
Aug, 2014
(11 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9493582 | Alkylated cyclodextrin compositions and processes for preparing and using the same |
Feb, 2033
(7 years from now) | Active |
| US9023790 | Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin |
Jul, 2031
(5 years from now) | Active |
| US9358297 | Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin |
Jun, 2031
(5 years from now) | Active |
| US10117951 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US9750822 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US8410077 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
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 Noxafil's patents.
Latest Legal Activities on Noxafil's Patents
Given below is the list of recent legal activities going on the following patents of Noxafil.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2024 | US9493582 |
| Maintenance Fee Reminder Mailed
Critical | 29 Apr, 2024 | US8263600 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Nov, 2023 | US9358297 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US10117951 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US8410077 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US9750822 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US9493582 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Oct, 2022 | US9023790 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Apr, 2022 | US10117951 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Feb, 2021 | US9750822 |
FDA has granted several exclusivities to Noxafil. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Noxafil, 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
Noxafil.
Exclusivity Information
Noxafil holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Noxafil's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 15, 2011 |
| New Patient Population(NPP) | May 31, 2024 |
| New Indication(I-881) | Jun 17, 2024 |
| Orphan Drug Exclusivity(ODE-355) | Jun 17, 2028 |
Several oppositions have been filed on Noxafil'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 Noxafil's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Noxafil patents.
Noxafil's Oppositions Filed in EPO
Noxafil has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 25, 2022, by Generics (U.K.) Limited. This opposition was filed on patent number EP18171672A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP18171672A | May, 2022 | Fresenius Kabi Deutschland GmbH | Granted and Under Opposition |
| EP18171672A | May, 2022 | Aera A/S | Granted and Under Opposition |
| EP18171672A | May, 2022 | Ethypharm | Granted and Under Opposition |
| EP18171672A | May, 2022 | Generics (U.K.) Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but
Noxafil 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 Noxafil's family patents as well as insights into
ongoing legal events
on those patents.
Noxafil's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Noxafil's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 27, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Noxafil Generic API suppliers:
Posaconazole is the generic name for the brand Noxafil. 20 different companies have already filed for the generic of Noxafil, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Noxafil's generic
How can I launch a generic of Noxafil before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Noxafil's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Noxafil'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 Noxafil -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg/mL | 28 Feb, 2011 | 1 | 19 Jul, 2019 | Extinguished | |
| 100 mg | 16 Jun, 2014 | 1 | 19 Jul, 2019 | Extinguished | |
| 18 mg/mL, 16.7 mL vials | 24 Nov, 2015 | 1 | 25 May, 2022 | 04 Jul, 2031 | Eligible |
About Noxafil
Noxafil is a drug owned by Merck Sharp And Dohme Corp. It is used for preventing and treating fungal infections in severely immunocompromised patients aged 2 years and older. Noxafil uses Posaconazole as an active ingredient. Noxafil was launched by Merck Sharp Dohme in 2014.
Approval Date:
Noxafil was approved by FDA for market use on 13 March, 2014.
Active Ingredient:
Noxafil uses Posaconazole as the active ingredient. Check out other Drugs and Companies using Posaconazole ingredient
Treatment:
Noxafil is used for preventing and treating fungal infections in severely immunocompromised patients aged 2 years and older.
Dosage:
Noxafil is available in the following dosage forms - tablet, delayed release form for oral use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/16.7ML (18MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE | Discontinued | ORAL |
Noxafil is a drug owned by Schering Corp. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Noxafil's patents have been open to challenges since 15 September, 2010. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 17, 2028. Details of Noxafil'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). | |||
| US8263600 | Antifungal composition with enhanced bioavailability |
Apr, 2022
(3 years ago) |
Expired
|
| US5661151 | Tetrahydrofuran antifungals |
Jul, 2019
(6 years ago) |
Expired
|
| US6958337 | Crystalline antifungal polymorph |
Oct, 2018
(7 years ago) |
Expired
|
| US5703079 | Tetrahydrofuran antifungals |
Aug, 2014
(11 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 Noxafil's patents.
Latest Legal Activities on Noxafil's Patents
Given below is the list of recent legal activities going on the following patents of Noxafil.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2024 | US9493582 |
| Maintenance Fee Reminder Mailed
Critical | 29 Apr, 2024 | US8263600 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Nov, 2023 | US9358297 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US10117951 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US8410077 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US9750822 |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US9493582 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Oct, 2022 | US9023790 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Apr, 2022 | US10117951 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Feb, 2021 | US9750822 |
FDA has granted several exclusivities to Noxafil. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Noxafil, 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
Noxafil.
Exclusivity Information
Noxafil holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Noxafil's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 15, 2011 |
| New Patient Population(NPP) | May 31, 2024 |
| New Indication(I-881) | Jun 17, 2024 |
| Orphan Drug Exclusivity(ODE-355) | Jun 17, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Noxafil 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 Noxafil's family patents as well as insights into
ongoing legal events
on those patents.
Noxafil's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Noxafil's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 17, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Noxafil Generic API suppliers:
Posaconazole is the generic name for the brand Noxafil. 20 different companies have already filed for the generic of Noxafil, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Noxafil's generic
How can I launch a generic of Noxafil before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Noxafil's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Noxafil'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 Noxafil -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg/mL | 28 Feb, 2011 | 1 | 19 Jul, 2019 | Extinguished | |
| 100 mg | 16 Jun, 2014 | 1 | 19 Jul, 2019 | Extinguished | |
| 18 mg/mL, 16.7 mL vials | 24 Nov, 2015 | 1 | 25 May, 2022 | 04 Jul, 2031 | Eligible |
About Noxafil
Noxafil is a drug owned by Schering Corp. It is used for preventing and treating fungal infections in severely immunocompromised patients aged 2 years and older. Noxafil uses Posaconazole as an active ingredient. Noxafil was launched by Schering in 2006.
Approval Date:
Noxafil was approved by FDA for market use on 15 September, 2006.
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 Noxafil is 15 September, 2006, its NCE-1 date is estimated to be 15 September, 2010.
Active Ingredient:
Noxafil uses Posaconazole as the active ingredient. Check out other Drugs and Companies using Posaconazole ingredient
Treatment:
Noxafil is used for preventing and treating fungal infections in severely immunocompromised patients aged 2 years and older.
Dosage:
Noxafil is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/ML | SUSPENSION | Prescription | ORAL |