Tolbutamide - Generic Drug Details

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What are the generic drug sources for tolbutamide and what is the scope of patent protection?

Tolbutamide is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Alra, Ani Pharms, Ascot, Barr, Chartwell Rx, Dava Pharms Inc, Norvium Bioscience, Parke Davis, Purepac Pharm, Sandoz, Superpharm, Vangard, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for tolbutamide.

Summary for tolbutamide

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	18
Drug Master File Entries:	15
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	30
Patent Applications:	7,287
What excipients (inactive ingredients) are in tolbutamide?	tolbutamide excipients list
DailyMed Link:	tolbutamide at DailyMed

Recent Clinical Trials for tolbutamide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 1
Radboud University	Phase 1
Oregon State University	Phase 1

See all tolbutamide clinical trials

Medical Subject Heading (MeSH) Categories for tolbutamide

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for tolbutamide

A10BB	Sulfonylureas
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

V04CA	Tests for diabetes
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for tolbutamide

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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
Superpharm	TOLBUTAMIDE	tolbutamide	TABLET;ORAL	088893-001	Nov 19, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vangard	TOLBUTAMIDE	tolbutamide	TABLET;ORAL	087876-001	Apr 20, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	TOLBUTAMIDE	tolbutamide	TABLET;ORAL	086574-001	Approved Prior to Jan 1, 1982		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

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