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

See all DOLASETRON MESYLATE clinical trials

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

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for DOLASETRON MESYLATE

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Glossary

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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	TABLET;ORAL	020623-001	Sep 11, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	Sep 11, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-003	Dec 11, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	Sep 11, 1997	⤷ Sign Up	⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-003	Dec 11, 2001	⤷ Sign Up	⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-001	Sep 11, 1997	⤷ Sign Up	⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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