Pennsaid is a drug owned by Horizon Therapeutics Ireland Dac. It is protected by 19 US drug patents filed from 2014 to 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 09, 2030. Details of Pennsaid'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). | |||
| US8546450 | Treatment of pain with topical diclofenac compounds |
Aug, 2030
(5 years from now) | Active |
| US8741956 | Treatment of pain with topical diclofenac |
Jul, 2029
(4 years from now) | Active |
| US9370501 | Treatment of pain with topical diclofenac |
Jul, 2029
(4 years from now) | Active |
| US8217078 | Treatment of pain with topical diclofenac |
Jul, 2029
(4 years from now) | Active |
| US9375412 | Treatment of pain with topical diclofenac |
Jul, 2029
(4 years from now) | Active |
| US9415029 | Treatment of pain with topical diclofenac |
Jul, 2029
(4 years from now) | Active |
| US8618164 | Treatment of pain with topical diclofenac compounds |
Jul, 2029
(4 years from now) | Active |
| US8252838 | Diclofenac topical formulation |
Apr, 2028
(3 years from now) | Active |
| US9220784 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US9168304 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US9339552 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US9066913 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US9539335 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US8563613 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US9339551 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US8871809 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US9168305 | Diclofenac topical formulation |
Oct, 2027
(2 years from now) | Active |
| US9132110 | Treatment of pain with topical diclofenac |
Oct, 2027
(2 years from now) | Active |
| US9101591 | Diclofenac topical formulation |
Oct, 2027
(2 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 Pennsaid's patents.
Latest Legal Activities on Pennsaid's Patents
Given below is the list of recent legal activities going on the following patents of Pennsaid.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 24 Jun, 2024 | US9339551 (Litigated) |
| Expire Patent Critical | 24 Jun, 2024 | US9339552 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 15 Apr, 2024 | US8252838 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 08 Apr, 2024 | US9415029 |
| Maintenance Fee Reminder Mailed Critical | 26 Feb, 2024 | US8217078 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 19 Feb, 2024 | US9375412 |
| Maintenance Fee Reminder Mailed Critical | 12 Feb, 2024 | US9370501 |
| Maintenance Fee Reminder Mailed Critical | 08 Jan, 2024 | US9339551 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 08 Jan, 2024 | US9339552 (Litigated) |
| Expire Patent Critical | 23 Oct, 2023 | US9132110 (Litigated) |
FDA has granted several exclusivities to Pennsaid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pennsaid, 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 Pennsaid.
Exclusivity Information
Pennsaid holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Pennsaid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Nov 04, 2012 |
| New Product(NP) | Jan 16, 2017 |
US patents provide insights into the exclusivity only within the United States, but Pennsaid 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 Pennsaid's family patents as well as insights into ongoing legal events on those patents.
Pennsaid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pennsaid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 09, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pennsaid Generic API suppliers:
Diclofenac Sodium is the generic name for the brand Pennsaid. 41 different companies have already filed for the generic of Pennsaid, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pennsaid's generic
How can I launch a generic of Pennsaid before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pennsaid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pennsaid'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 Pennsaid -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.015 | 11 Jul, 2012 | 1 | 27 May, 2014 | 10 Jul, 2029 | Eligible |
| 0.02 | 03 Jun, 2014 | 1 | 09 Aug, 2030 | Extinguished |
Alternative Brands for Pennsaid
Pennsaid which is used for treating pain and osteoarthritis in the knee., has several other brand drugs using the same active ingredient (Diclofenac Sodium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Falcon Pharms |
| |
| Fougera Pharms |
| |
| Javelin Pharms Inc |
| |
| Pfizer |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diclofenac Sodium, Pennsaid's active ingredient. Check the complete list of approved generic manufacturers for Pennsaid
About Pennsaid
Pennsaid is a drug owned by Horizon Therapeutics Ireland Dac. It is used for treating pain and osteoarthritis in the knee. Pennsaid uses Diclofenac Sodium as an active ingredient. Pennsaid was launched by Horizon in 2014.
Approval Date:
Pennsaid was approved by FDA for market use on 16 January, 2014.
Active Ingredient:
Pennsaid uses Diclofenac Sodium as the active ingredient. Check out other Drugs and Companies using Diclofenac Sodium ingredient
Treatment:
Pennsaid is used for treating pain and osteoarthritis in the knee.
Dosage:
Pennsaid is available in solution form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | TOPICAL |
Pennsaid is a drug owned by Nuvo Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2013 to 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 09, 2030. Details of Pennsaid'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). | |||
| US8546450 | Treatment of pain with topical diclofenac compounds |
Aug, 2030
(5 years from now) | Active |
| US8217078 | Treatment of pain with topical diclofenac |
Jul, 2029
(4 years from now) | Active |
| US8618164 | Treatment of pain with topical diclofenac compounds |
Jul, 2029
(4 years from now) | Active |
| US8741956 | Treatment of pain with topical diclofenac |
Jul, 2029
(4 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 Pennsaid's patents.
Latest Legal Activities on Pennsaid's Patents
Given below is the list of recent legal activities going on the following patents of Pennsaid.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Expire Patent Critical | 24 Jun, 2024 | US9339551 (Litigated) |
| Expire Patent Critical | 24 Jun, 2024 | US9339552 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 15 Apr, 2024 | US8252838 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 08 Apr, 2024 | US9415029 |
| Maintenance Fee Reminder Mailed Critical | 26 Feb, 2024 | US8217078 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 19 Feb, 2024 | US9375412 |
| Maintenance Fee Reminder Mailed Critical | 12 Feb, 2024 | US9370501 |
| Maintenance Fee Reminder Mailed Critical | 08 Jan, 2024 | US9339551 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 08 Jan, 2024 | US9339552 (Litigated) |
| Expire Patent Critical | 23 Oct, 2023 | US9132110 (Litigated) |
FDA has granted several exclusivities to Pennsaid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pennsaid, 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 Pennsaid.
Exclusivity Information
Pennsaid holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Pennsaid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Nov 04, 2012 |
| New Product(NP) | Jan 16, 2017 |
US patents provide insights into the exclusivity only within the United States, but Pennsaid 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 Pennsaid's family patents as well as insights into ongoing legal events on those patents.
Pennsaid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pennsaid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 09, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pennsaid Generic API suppliers:
Diclofenac Sodium is the generic name for the brand Pennsaid. 41 different companies have already filed for the generic of Pennsaid, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pennsaid's generic
How can I launch a generic of Pennsaid before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pennsaid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pennsaid'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 Pennsaid -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.015 | 11 Jul, 2012 | 1 | 27 May, 2014 | 10 Jul, 2029 | Eligible |
| 0.02 | 03 Jun, 2014 | 1 | 09 Aug, 2030 | Extinguished |
Alternative Brands for Pennsaid
Pennsaid which is used for treating pain and osteoarthritis in the knee., has several other brand drugs using the same active ingredient (Diclofenac Sodium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Falcon Pharms |
| |
| Fougera Pharms |
| |
| Javelin Pharms Inc |
| |
| Pfizer |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diclofenac Sodium, Pennsaid's active ingredient. Check the complete list of approved generic manufacturers for Pennsaid
About Pennsaid
Pennsaid is a drug owned by Nuvo Pharmaceuticals Inc. It is used for treating pain and osteoarthritis in the knee. Pennsaid uses Diclofenac Sodium as an active ingredient. Pennsaid was launched by Nuvo Pharms Inc in 2009.
Approval Date:
Pennsaid was approved by FDA for market use on 04 November, 2009.
Active Ingredient:
Pennsaid uses Diclofenac Sodium as the active ingredient. Check out other Drugs and Companies using Diclofenac Sodium ingredient
Treatment:
Pennsaid is used for treating pain and osteoarthritis in the knee.
Dosage:
Pennsaid is available in solution form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | TOPICAL |