DrugPatentWatch Database Preview➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing
« Back to Dashboard
Diclofenacis the generic ingredient in sixteen branded drugs marketed by Zyla, Inst Biochem, Ibsa Inst Bio, Bionpharma Inc, Strides Pharma, Assertio, Par Form, Novartis, Amici, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, Watson Labs Teva, Actavis Mid Atlantic, Akorn, Amneal Pharms, Cipla, Encube, Glenmark Pharms Ltd, Mylan, Perrigo Uk Finco, Taro, Tolmar, Fougera Pharms, Glaxosmithkline Cons, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, Mylan Labs Ltd, Javelin Pharms Inc, Apotex Inc, Cadila, Lupin Ltd, Novast Labs, Novel Labs Inc, Teligent, Twi Pharms, Watson Labs Inc, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Carlsbad, Chartwell Rx, Micro Labs Usa, Mylan Pharms Inc, Pliva, Roxane, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, and Yung Shin Pharm, and is included in seventy-six NDAs. There are thirty-seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Diclofenac has forty-four patent family members in twenty-three countries.
There are forty-seven drug master file entries for diclofenac. One supplier is listed for this compound. There are seven tentative approvals for this compound.
Summary for diclofenac
|Drug Master File Entries:||47|
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||92|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for diclofenac|
|Drug Sales Revenues:||Drug sales revenues for diclofenac|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for diclofenac|
|DailyMed Link:||diclofenac at DailyMed|
Recent Clinical Trials for diclofenac
Identify potential brand extensions & 505(b)(2) entrants
|Theodor Bilharz Research Institute||Phase 4|
|Joanneum Research Forschungsgesellschaft mbH||N/A|
|Olakunle Ifeoluwa Makinde||N/A|
Generic filers with tentative approvals for DICLOFENAC
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for diclofenac
|Drug Class||Nonsteroidal Anti-inflammatory Drug |
|Mechanism of Action||Cyclooxygenase Inhibitors |
|Physiological Effect||Decreased Prostaglandin Production |
Medical Subject Heading (MeSH) Categories for diclofenac
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Akorn||DICLOFENAC SODIUM||diclofenac sodium||GEL;TOPICAL||209484-001||Nov 21, 2018||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Horizon||PENNSAID||diclofenac sodium||SOLUTION;TOPICAL||204623-001||Jan 16, 2014||RX||Yes||Yes||Start Trial||Start Trial||Y||Start Trial|
|Horizon||PENNSAID||diclofenac sodium||SOLUTION;TOPICAL||204623-001||Jan 16, 2014||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Novartis||VOLTAREN||diclofenac sodium||TABLET, DELAYED RELEASE;ORAL||019201-002||Jul 28, 1988||DISCN||Yes||No||Start Trial||Start Trial||Start Trial|
|Lupin Ltd||DICLOFENAC SODIUM||diclofenac sodium||SOLUTION;TOPICAL||204132-001||Aug 20, 2015||AT||RX||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.