PENNSAID Drug Patent Profile
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Which patents cover Pennsaid, and what generic alternatives are available?
Pennsaid is a drug marketed by Horizon and Nuvo Pharms Inc and is included in two NDAs. There are nineteen patents protecting this drug and two Paragraph IV challenges.
This drug has eighteen patent family members in fourteen countries.
The generic ingredient in PENNSAID is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-nine suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pennsaid
A generic version of PENNSAID was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26th, 1996.
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Summary for PENNSAID
| International Patents: | 18 |
| US Patents: | 19 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,203 |
| Drug Prices: | Drug price information for PENNSAID |
| Drug Sales Revenues: | Drug sales revenues for PENNSAID |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PENNSAID |
| What excipients (inactive ingredients) are in PENNSAID? | PENNSAID excipients list |
| DailyMed Link: | PENNSAID at DailyMed |
Recent Clinical Trials for PENNSAID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nathan Wei, MD, FACP, FACR: | Phase 3 |
| Medtronic - MITG | Phase 3 |
| Arthritis Treatment Center, Maryland | Phase 3 |
Pharmacology for PENNSAID
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Paragraph IV (Patent) Challenges for PENNSAID
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PENNSAID | Topical Solution | diclofenac sodium | 2.0% | 204623 | 1 | 2014-06-03 |
| PENNSAID | Topical Solution | diclofenac sodium | 1.5% | 020947 | 1 | 2012-07-11 |
US Patents and Regulatory Information for PENNSAID
PENNSAID is protected by twenty-one US patents.
Patents protecting PENNSAID
Treatment of pain with topical diclofenac
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
Treatment of pain with topical diclofenac
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
Treatment of pain with topical diclofenac compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
Treatment of pain with topical diclofenac compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Treatment of pain with topical diclofenac compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
Treatment of pain with topical diclofenac
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Treatment of pain with topical diclofenac
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
Treatment of pain with topical diclofenac
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
Treatment of pain with topical diclofenac
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
Treatment of pain with topical diclofenac
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
Diclofenac topical formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for PENNSAID
See the table below for patents covering PENNSAID around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 5432716 | ⤷ Sign Up | |
| Mexico | 2009004038 | GEL DE DICLOFENACO. (DICLOFENAC GEL.) | ⤷ Sign Up |
| Brazil | PI0717769 | FORMULAÇÃO DE GEL, MÉTODO PARA O TRATAMENTO DA OSTEOARTRITE EM UM INDIVÍDUO SOFRENDO DE DOR ARTICULAR, E, USO DE DICLOFENAC DE SÓDIO | ⤷ Sign Up |
| Japan | 2010506952 | ⤷ Sign Up | |
| Denmark | 2086504 | ⤷ Sign Up | |
| Israel | 198161 | ג'ל דיכלופני (Diclofenac gel) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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