Details for New Drug Application (NDA): 206976
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The generic ingredient in LICART is diclofenac epolamine. There are forty-seven drug master file entries for this compound. Seven 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:
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 | |||||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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