Details for New Drug Application (NDA): 206976
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NDA 206976 describes LICART, which is a drug marketed by Ibsa Inst Bio and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LICART profile page.
The generic ingredient in LICART is diclofenac epolamine. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.
The generic ingredient in LICART is diclofenac epolamine. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.
Summary for 206976
| Tradename: | LICART |
| Applicant: | Ibsa Inst Bio |
| Ingredient: | diclofenac epolamine |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206976
Generic Entry Date for 206976*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
SYSTEM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 206976
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 206976
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LICART | diclofenac epolamine | SYSTEM;TOPICAL | 206976 | NDA | IBSA Pharma Inc. | 71858-0305 | 71858-0305-2 | 1 POUCH in 1 CARTON (71858-0305-2) / 2 SYSTEM in 1 POUCH (71858-0305-1) |
| LICART | diclofenac epolamine | SYSTEM;TOPICAL | 206976 | NDA | IBSA Pharma Inc. | 71858-0305 | 71858-0305-5 | 3 POUCH in 1 CARTON (71858-0305-5) / 5 SYSTEM in 1 POUCH (71858-0305-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TOPICAL | Strength | 1.3% | ||||
| Approval Date: | Dec 19, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | 11,344,520 | Patent Expiration: | Feb 20, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED | ||||||||
| Patent: | 11,351,133 | Patent Expiration: | Feb 20, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED | ||||||||
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