BALSALAZIDE DISODIUM - Generic Drug Details
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What are the generic drug sources for balsalazide disodium and what is the scope of patent protection?
Balsalazide disodium
is the generic ingredient in three branded drugs marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus Lifesciences, Valeant Pharms Intl, and Strides Pharma, and is included in seven 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-five patent family members in twelve countries.
There are ten drug master file entries for balsalazide disodium. Nine suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for BALSALAZIDE DISODIUM
International Patents: | 45 |
US Patents: | 6 |
Tradenames: | 3 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 221 |
Clinical Trials: | 7 |
Patent Applications: | 3,495 |
Drug Prices: | Drug price trends for BALSALAZIDE DISODIUM |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BALSALAZIDE DISODIUM |
What excipients (inactive ingredients) are in BALSALAZIDE DISODIUM? | BALSALAZIDE DISODIUM excipients list |
DailyMed Link: | BALSALAZIDE DISODIUM at DailyMed |
Recent Clinical Trials for BALSALAZIDE DISODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Valeant Pharmaceuticals International, Inc. | Phase 3 |
Bausch Health Americas, Inc. | Phase 3 |
Roxane Laboratories | N/A |
Generic filers with tentative approvals for BALSALAZIDE DISODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 1.1GM | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 1.1G | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for BALSALAZIDE DISODIUM
Drug Class | Aminosalicylate |
Anatomical Therapeutic Chemical (ATC) Classes for BALSALAZIDE DISODIUM
Paragraph IV (Patent) Challenges for BALSALAZIDE DISODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
COLAZAL | Capsules | balsalazide disodium | 750 mg | 020610 | 1 | 2022-05-26 |
GIAZO | Tablets | balsalazide disodium | 1.1 g | 022205 | 1 | 2013-11-05 |
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 | 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 | ||
Valeant Pharms Intl | GIAZO | balsalazide disodium | TABLET;ORAL | 022205-001 | Feb 3, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Dash Pharms Natco | BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077807-001 | Dec 28, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BALSALAZIDE DISODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Valeant Pharms Intl | COLAZAL | balsalazide disodium | CAPSULE;ORAL | 020610-001 | Jul 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Valeant Pharms Intl | GIAZO | balsalazide disodium | TABLET;ORAL | 022205-001 | Feb 3, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BALSALAZIDE DISODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 603744 | Balsalazide formulations and manufacture and use thereof | ⤷ Sign Up |
New Zealand | 593132 | BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF | ⤷ Sign Up |
Canada | 2668441 | PREPARATIONS A BASE DE DERIVES D'ACIDE 2-HYDROXY-5-PHENYLAZOBENZOIQUE ET LEURS APPLICATIONS (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2007025146 | ⤷ Sign Up | |
European Patent Office | 2563117 | FORMULATIONS ET UTILISATIONS DE DÉRIVÉS D'ACIDE 2-HYDROXY-5-PHÉNYLAZOBENZOÏQUE POUR LE TRAITEMENT DE SUJETS MÂLES (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES FOR THE TREATMENT OF MALES) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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