Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - Generic Drug Details

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What are the generic sources for citric acid; magnesium oxide; sodium picosulfate and what is the scope of patent protection?

Citric acid; magnesium oxide; sodium picosulfate is the generic ingredient in two branded drugs marketed by Ferring Pharms Inc and is included in two NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Citric acid; magnesium oxide; sodium picosulfate has forty-two patent family members in twenty-four countries.

There are five drug master file entries for citric acid; magnesium oxide; sodium picosulfate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

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

SponsorPhase
The Cleveland ClinicPhase 4
Ferring PharmaceuticalsPhase 4
Ferring PharmaceuticalsPhase 3

See all CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE clinical trials

Recent Litigation for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Ferring Pharmaceuticals Inc. v. Novel Laboratories, Inc.2017-07-05
Ferring Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2017-04-19
Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc.2015-02-20

See all CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE litigation

Generic filers with tentative approvals for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Tradename Dosage Ingredient NDA Submissiondate
CLENPIQ SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 209589 2019-02-11
PREPOPIK FOR SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 202535 2014-05-21

US Patents and Regulatory Information for CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc CLENPIQ citric acid; magnesium oxide; sodium picosulfate SOLUTION;ORAL 209589-001 Nov 28, 2017 RX Yes Yes   Start Trial   Start Trial Y   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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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.