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Pennsaid Drug Profile
Which patents cover Pennsaid, and when can generic versions of Pennsaid launch?
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. Eighty-six suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for Pennsaid
| International Patents: | 18 |
| US Patents: | 19 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 72 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,789 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | Pennsaid at DailyMed |
Pharmacology for Pennsaid
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
US Patents and Regulatory Information for Pennsaid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon Pharma | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Horizon Pharma | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Nuvo Pharms Inc | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 020947-001 | Nov 4, 2009 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Horizon Pharma | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | RX | Yes | Yes | ➤ 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 |
Paragraph IV (Patent) Challenges for PENNSAID
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Topical Solution | 2.0% | ➤ Subscribe | 2014-06-03 |
| ➤ Subscribe | Topical Solution | 1.5% | ➤ Subscribe | 2012-07-11 |
International Patents for Pennsaid
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2008049020 | ➤ Sign Up |
| South Africa | 200903135 | ➤ Sign Up |
| Canada | 2666398 | ➤ Sign Up |
| European Patent Office | 2626063 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
