COLAZAL Drug Patent Profile
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When do Colazal patents expire, and when can generic versions of Colazal launch?
Colazal is a drug marketed by Valeant Pharms Intl and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-six patent family members in twelve countries.
The generic ingredient in COLAZAL is balsalazide disodium. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Colazal
A generic version of COLAZAL was approved as balsalazide disodium by APOTEX INC on December 28th, 2007.
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Summary for COLAZAL
| International Patents: | 36 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 221 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,031 |
| Drug Prices: | Drug price information for COLAZAL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COLAZAL |
| What excipients (inactive ingredients) are in COLAZAL? | COLAZAL excipients list |
| DailyMed Link: | COLAZAL at DailyMed |
Recent Clinical Trials for COLAZAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roxane Laboratories | N/A |
| Mylan Pharmaceuticals | Phase 1 |
Pharmacology for COLAZAL
| Drug Class | Aminosalicylate |
Paragraph IV (Patent) Challenges for COLAZAL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| COLAZAL | Capsules | balsalazide disodium | 750 mg | 020610 | 1 | 2022-05-26 |
US Patents and Regulatory Information for COLAZAL
COLAZAL is protected by two US patents.
Patents protecting COLAZAL
Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | COLAZAL | balsalazide disodium | CAPSULE;ORAL | 020610-001 | Jul 18, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
Expired US Patents for COLAZAL
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for COLAZAL
See the table below for patents covering COLAZAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 2080796 | 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES | ⤷ Sign Up |
| Canada | 2816276 | PREPARATIONS DE BALSALAZIDE, LEUR PROCEDE D'OBTENTION ET LEURS UTILISATIONS (BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF) | ⤷ Sign Up |
| European Patent Office | 2529729 | PrĂ©parations de balsalazide et leur fabrication (Balsalazide formulations and manufacture thereof) | ⤷ Sign Up |
| Japan | S6225656 | ⤷ Sign Up | |
| Italy | 1138450 | DERIVATI DELL'ACIDO 2-IDROSSI-5-FENILAZOBENZOICO,COMPOSIZIONI FARMACEUTICHE CHE LI CONTENGONO E PROCEDIMENTO PER LA LORO PREPARAZIONE | ⤷ Sign Up |
| Japan | S5753449 | 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVE, MANUFACTURE AND MEDICINAL COMPOSITION | ⤷ Sign Up |
| China | 102670626 | Balsalazide formulations and manufacture and use thereof | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.
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