BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Julphar
Cantor Fitzgerald
Covington
Merck
Healthtrust
Teva
Queensland Health
US Army
Mallinckrodt

Generated: January 16, 2018

DrugPatentWatch Database Preview

Balsalazide disodium - Generic Drug Details

« Back to Dashboard

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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has fifty-seven patent family members in nineteen countries.

There are ten drug master file entries for balsalazide disodium. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for balsalazide disodium
Pharmacology for balsalazide disodium
Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate
Tentative approvals for BALSALAZIDE DISODIUM
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe1.1GTABLET;ORAL

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
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806-001 Dec 28, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mylan BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm Inc BALSALAZIDE DISODIUM balsalazide disodium TABLET;ORAL 206336-001 Sep 8, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883-001 Dec 28, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for balsalazide disodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,921,344 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for balsalazide disodium

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Julphar
Harvard Business School
Fuji
Moodys
Novartis
AstraZeneca
Teva
US Department of Justice

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.

botpot