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Last Updated: August 11, 2020

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DICLOFENAC SODIUM Drug Profile

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When do Diclofenac Sodium patents expire, and when can generic versions of Diclofenac Sodium launch?

Diclofenac Sodium is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Cipla, Encube, Glenmark Pharms Ltd, Hi Tech, Mylan, Perrigo Uk Finco, Taro, Tolmar, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, Mylan Labs Ltd, Cadila, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Twi Pharms, Watson Labs Inc, Actavis Elizabeth, Carlsbad, Casi Pharms Inc, Micro Labs Usa, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Actavis Labs Fl Inc, Exela Holdings, Sandoz, and Yung Shin Pharm. and is included in fifty-one NDAs.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Drug patent expirations by year for DICLOFENAC SODIUM
Drug Prices for DICLOFENAC SODIUM

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Drug Sales Revenue Trends for DICLOFENAC SODIUM

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Recent Clinical Trials for DICLOFENAC SODIUM

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SponsorPhase
Assiut UniversityN/A
Guang'anmen Hospital of China Academy of Chinese Medical SciencesN/A
William N HandelmanPhase 2

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Pharmacology for DICLOFENAC SODIUM
Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM
Tradename Dosage Ingredient NDA Submissiondate
DYLOJECT SOLUTION;INTRAVENOUS diclofenac sodium 022396 2015-12-15
PENNSAID SOLUTION;TOPICAL diclofenac sodium 204623 2014-06-03
PENNSAID SOLUTION;TOPICAL diclofenac sodium 020947 2012-07-11
SOLARAZE GEL;TOPICAL diclofenac sodium 021005 2009-12-16

US Patents and Regulatory Information for DICLOFENAC SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281-003 Feb 12, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Carlsbad DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075185-002 Nov 13, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074459-001 Jun 25, 1997 DISCN 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

Expired US Patents for DICLOFENAC SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998   Start Trial   Start Trial
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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