DOLASETRON MESYLATE - Generic Drug Details
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What are the generic drug sources for dolasetron mesylate and what is the scope of freedom to operate?
Dolasetron mesylate
is the generic ingredient in one branded drug marketed by Validus Pharms and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for dolasetron mesylate. One supplier is listed for this compound.
Summary for DOLASETRON MESYLATE
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 185 |
Clinical Trials: | 4 |
Patent Applications: | 5,521 |
What excipients (inactive ingredients) are in DOLASETRON MESYLATE? | DOLASETRON MESYLATE excipients list |
DailyMed Link: | DOLASETRON MESYLATE at DailyMed |
Recent Clinical Trials for DOLASETRON MESYLATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vanderbilt University | N/A |
University of Washington | N/A |
University of Southern California | N/A |
Pharmacology for DOLASETRON MESYLATE
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DOLASETRON MESYLATE
US Patents and Regulatory Information for DOLASETRON MESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Validus Pharms | ANZEMET | dolasetron mesylate | INJECTABLE;INJECTION | 020624-002 | Sep 11, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Validus Pharms | ANZEMET | dolasetron mesylate | TABLET;ORAL | 020623-002 | Sep 11, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Validus Pharms | ANZEMET | dolasetron mesylate | TABLET;ORAL | 020623-001 | Sep 11, 1997 | DISCN | Yes | 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 DOLASETRON MESYLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Validus Pharms | ANZEMET | dolasetron mesylate | INJECTABLE;INJECTION | 020624-003 | Dec 11, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | ANZEMET | dolasetron mesylate | INJECTABLE;INJECTION | 020624-002 | Sep 11, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | ANZEMET | dolasetron mesylate | INJECTABLE;INJECTION | 020624-001 | Sep 11, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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