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Generated: May 29, 2017

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Diclofenac sodium; misoprostol - Generic Drug Details

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

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

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

Summary for Generic Name: diclofenac sodium; misoprostol

Tradenames:2
Patents:1
Applicants:5
NDAs:5
Drug Master File Entries: see list47
Suppliers / Packagers: see list19
Clinical Trials: see list1,060
Drug Prices:see low prices
DailyMed Link:diclofenac sodium; misoprostol at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL203995-002Nov 25, 2016ABRXNoNo► Subscribe► Subscribe
Exela Holdings
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200540-001Mar 14, 2014ABRXNoNo► Subscribe► Subscribe
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 1997ABRXYesNo► Subscribe► Subscribe
Actavis Labs Fl Inc
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-002Jul 9, 2012ABRXNoNo► Subscribe► Subscribe
Sandoz
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158-001May 9, 2013ABRXNoNo► Subscribe► Subscribe
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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 verifification 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.

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