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Last Updated: December 16, 2019

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Diclofenac sodium; misoprostol - Generic Drug Details

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What are the generic sources for diclofenac sodium; misoprostol and what is the scope of freedom to operate?

Diclofenac sodium; misoprostol is the generic ingredient in two branded drugs marketed by Gd Searle Llc, Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, and Sandoz, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-seven drug master file entries for diclofenac sodium; misoprostol. Eleven suppliers are listed for this compound.

Recent Litigation for diclofenac sodium; misoprostol

Identify potential future generic entrants

District Court Litigation
Case NameDate
ASTRAZENECA AB v. DR. REDDY'S LABORATORIES INC.2011-04-21

See all diclofenac sodium; misoprostol litigation

Pharmacology for diclofenac sodium; misoprostol
Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM; MISOPROSTOL
Tradename Dosage Ingredient NDA Submissiondate
ARTHROTEC TABLET, DELAYED RELEASE;ORAL diclofenac sodium; misoprostol 020607 2009-06-29
ARTHROTEC TABLET, DELAYED RELEASE;ORAL diclofenac sodium; misoprostol 020607 2008-11-28

US Patents and Regulatory Information for diclofenac sodium; misoprostol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exela Holdings DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540-002 Mar 14, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200158-001 May 9, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Exela Holdings DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540-001 Mar 14, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 203995-002 Nov 25, 2016 AB 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

Expired US Patents for diclofenac sodium; misoprostol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997   Start Trial   Start Trial
Gd Searle Llc ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-001 Dec 24, 1997   Start Trial   Start Trial
Gd Searle Llc ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997   Start Trial   Start Trial
Gd Searle Llc ARTHROTEC diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 020607-002 Dec 24, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
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Johnson and Johnson
Merck
Colorcon

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