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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, Hikma, Mylan, 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 are two tentative approvals for this compound.
Summary for BALSALAZIDE DISODIUM
International Patents: | 47 |
US Patents: | 6 |
Tradenames: | 3 |
Applicants: | 5 |
NDAs: | 6 |
Drug Master File Entries: | 10 |
Suppliers / Packagers: | 7 |
Bulk Api Vendors: | 162 |
Clinical Trials: | 7 |
Patent Applications: | 4,634 |
Drug Prices: | Drug price trends for BALSALAZIDE DISODIUM |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BALSALAZIDE DISODIUM |
DailyMed Link: | BALSALAZIDE DISODIUM at DailyMed |
Recent Clinical Trials for BALSALAZIDE DISODIUM
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Sponsor | Phase |
---|---|
Valeant Pharmaceuticals International, Inc. | Phase 3 |
Roxane Laboratories | N/A |
Mylan Pharmaceuticals | Phase 1 |
Generic filers with tentative approvals for BALSALAZIDE DISODIUM
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 1.1GM | TABLET;ORAL |
Start Trial | Start Trial | 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 |
Paragraph IV (Patent) Challenges for BALSALAZIDE DISODIUM
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
GIAZO | TABLET;ORAL | balsalazide disodium | 022205 | 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 | Start Trial | Start Trial | Start Trial | ||||
Valeant Pharms Intl | COLAZAL | balsalazide disodium | CAPSULE;ORAL | 020610-001 | Jul 18, 2000 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Mylan | BALSALAZIDE DISODIUM | balsalazide disodium | CAPSULE;ORAL | 077807-001 | Dec 28, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Valeant Pharms Intl | GIAZO | balsalazide disodium | TABLET;ORAL | 022205-001 | Feb 3, 2012 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
>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 | Start Trial | Start Trial |
Valeant Pharms Intl | GIAZO | balsalazide disodium | TABLET;ORAL | 022205-001 | Feb 3, 2012 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BALSALAZIDE DISODIUM
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 2586427 | Start Trial |
Japan | 2012246322 | Start Trial |
Israel | 225695 | Start Trial |
Japan | 2013032395 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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