DICLOFENAC EPOLAMINE - Generic Drug Details
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What are the generic drug 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
*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 |
| University of Maryland | Early Phase 1 |
| Food and Drug Administration (FDA) | 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 | FLECTOR | diclofenac epolamine | SYSTEM;TOPICAL | 021234-001 | Jan 31, 2007 | 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 Inst Bio | LICART | diclofenac epolamine | SYSTEM;TOPICAL | 206976-001 | Dec 19, 2018 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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