BALSALAZIDE DISODIUM Drug Patent Profile
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Which patents cover Balsalazide Disodium, and when can generic versions of Balsalazide Disodium launch?
Balsalazide Disodium is a drug marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus Lifesciences, and Strides Pharma. and is included in five NDAs.
The generic ingredient in BALSALAZIDE DISODIUM is balsalazide disodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Balsalazide Disodium
A generic version of BALSALAZIDE DISODIUM was approved as balsalazide disodium by APOTEX INC on December 28th, 2007.
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Questions you can ask:
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Summary for BALSALAZIDE DISODIUM
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 221 |
| Clinical Trials: | 7 |
| Patent Applications: | 2,396 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Bausch Health Americas, Inc. | Phase 3 |
| Valeant Pharmaceuticals International, Inc. | Phase 3 |
| Roxane Laboratories | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex Inc | BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077883-001 | Dec 28, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Lifesciences | BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 217592-001 | Jun 8, 2023 | AB | RX | No | 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 | ||||
| Hikma | BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077806-001 | Dec 28, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Strides Pharma | BALSALAZIDE DISODIUM | balsalazide disodium | TABLET;ORAL | 206336-001 | Sep 8, 2015 | 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 |
