Diclofenac epolamine - Generic Drug Details
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What are the generic sources for diclofenac epolamine and what is the scope of patent protection?
Diclofenac epolamine
is the generic ingredient in two branded drugs marketed by Ibsa and Ibsa Inst Bio, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for diclofenac epolamine. Seven suppliers are listed for this compound.
Summary for diclofenac epolamine
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 25 |
Clinical Trials: | 5 |
Patent Applications: | 166 |
Drug Prices: | Drug price trends for diclofenac epolamine |
What excipients (inactive ingredients) are in diclofenac epolamine? | diclofenac epolamine excipients list |
DailyMed Link: | diclofenac epolamine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for diclofenac epolamine
Generic Entry Date for diclofenac epolamine*:
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.
Recent Clinical Trials for diclofenac epolamine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
IBSA Institut Biochimique SA | Phase 3 |
Food and Drug Administration (FDA) | Early Phase 1 |
University of Maryland, Baltimore | Early Phase 1 |
Pharmacology for diclofenac epolamine
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Anatomical Therapeutic Chemical (ATC) Classes for diclofenac epolamine
Paragraph IV (Patent) Challenges for DICLOFENAC EPOLAMINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FLECTOR | Topical Patch | diclofenac epolamine | 1.3% | 021234 | 1 | 2015-06-26 |
US Patents and Regulatory Information for diclofenac epolamine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ibsa Inst Bio | LICART | diclofenac epolamine | SYSTEM;TOPICAL | 206976-001 | Dec 19, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ibsa Inst Bio | LICART | diclofenac epolamine | SYSTEM;TOPICAL | 206976-001 | Dec 19, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ibsa | FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234-001 | Jan 31, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for diclofenac epolamine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ibsa | FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234-001 | Jan 31, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Ibsa | FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234-001 | Jan 31, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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