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 hundreds of leading biopharmaceutical companies globally:

Merck
Moodys
McKinsey
Chinese Patent Office
Citi
Daiichi Sankyo

Generated: July 21, 2019

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Balsalazide disodium - Generic Drug Details

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What are the generic sources for balsalazide disodium and what is the scope of balsalazide disodium freedom to operate?

Balsalazide disodium is the generic ingredient in three branded drugs marketed by Apotex Inc, Mylan, West-ward Pharms Int, Valeant Pharms Intl, and Par Pharm Inc, and is included in six NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has forty-seven patent family members in twelve countries.

There are ten drug master file entries for balsalazide disodium. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for balsalazide disodium
Drug ClassAminosalicylate
Generic filers with tentative approvals for BALSALAZIDE DISODIUM
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up1.1GTABLET;ORAL

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

US Patents and Regulatory Information for balsalazide disodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm Inc BALSALAZIDE DISODIUM balsalazide disodium TABLET;ORAL 206336-001 Sep 8, 2015 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883-001 Dec 28, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
US Department of Justice
Moodys
Colorcon
Chinese Patent Office
Medtronic

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.