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Details for Generic Name: diclofenac sodium; misoprostol

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

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

Summary for Generic Name: diclofenac sodium; misoprostol

Tradenames:2
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list46
Suppliers / Packaging: see list25

Clinical Trials for: diclofenac sodium; misoprostol

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
Status: Terminated Condition: Gastric Ulcer

Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Status: Active, not recruiting Condition: Lumbar Spinal Stenosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200540-001Mar 14, 2014RXNo<disabled><disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 1997RXNo<disabled><disabled>
Sandoz
DICLOFENAC SODIUM AND MISOPROSTOL
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL200158-002May 9, 2013RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: diclofenac sodium; misoprostol

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-001Dec 24, 19974,301,146<disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-002Dec 24, 19975,601,843<disabled>
Gd Searle Llc
ARTHROTEC
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL020607-002Dec 24, 19975,698,225<disabled>
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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