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Last Updated: February 27, 2021

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Diclofenac - Generic Drug Details

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What are the generic drug sources for diclofenac and what is the scope of patent protection?

Diclofenac is 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.

Drug Prices for diclofenac

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Drug Sales Revenue Trends for diclofenac

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Recent Clinical Trials for diclofenac

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Theodor Bilharz Research InstitutePhase 4
Joanneum Research Forschungsgesellschaft mbHN/A
Olakunle Ifeoluwa MakindeN/A

See all diclofenac clinical trials

Generic filers with tentative approvals for DICLOFENAC
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.5% W/WSOLUTION;TOPICAL
  Start Trial  Start Trial2%SOLUTION;TOPICAL
  Start Trial  Start Trial35MGCAPSULE;ORAL

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
Medical Subject Heading (MeSH) Categories for diclofenac
Paragraph IV (Patent) Challenges for DICLOFENAC
Tradename Dosage Ingredient NDA Submissiondate
ZORVOLEX CAPSULE;ORAL diclofenac 204592 2014-06-06

US Patents and Regulatory Information for diclofenac

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vpna DICLOFENAC SODIUM diclofenac sodium TABLET, EXTENDED RELEASE;ORAL 075492-001 Feb 11, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077-001 Mar 18, 2016 OTC No No   Start Trial   Start Trial   Start Trial
Tolmar DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 200936-001 Oct 28, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 202027-001 May 27, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 202852-001 Nov 24, 2014 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

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