ACARBOSE - Generic Drug Details

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What are the generic drug sources for acarbose and what is the scope of freedom to operate?

Acarbose is the generic ingredient in two branded drugs marketed by Avet Lifesciences, Dash Pharms, Hangzhou Zhongmei, Hikma, Impax Labs, Somerset Theraps Llc, Strides Pharma, Watson Labs, and Bayer Hlthcare, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for acarbose. Ten suppliers are listed for this compound.

Summary for ACARBOSE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	93
Patent Applications:	6,850
Drug Prices:	Drug price trends for ACARBOSE
What excipients (inactive ingredients) are in ACARBOSE?	ACARBOSE excipients list
DailyMed Link:	ACARBOSE at DailyMed

See drug prices for ACARBOSE

Recent Clinical Trials for ACARBOSE

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

Sponsor	Phase
CTC Clinical Trial Consultants AB	Phase 1
Empros Pharma AB	Phase 1
University of Zambia	Phase 3

See all ACARBOSE clinical trials

Pharmacology for ACARBOSE

Drug Class	alpha-Glucosidase Inhibitor
Mechanism of Action	alpha Glucosidase Inhibitors

Medical Subject Heading (MeSH) Categories for ACARBOSE

Glycoside Hydrolase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ACARBOSE

A10BF	Alpha glucosidase inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ACARBOSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRECOSE	Tablets	acarbose	25 mg, 50 mg and 100 mg	020482	1	2005-03-22

US Patents and Regulatory Information for ACARBOSE

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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
Hikma	ACARBOSE	acarbose	TABLET;ORAL	078470-002	May 7, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	ACARBOSE	acarbose	TABLET;ORAL	091343-002	Oct 17, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	ACARBOSE	acarbose	TABLET;ORAL	091343-003	Oct 17, 2013	AB	RX	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

Expired US Patents for ACARBOSE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-004	May 29, 1997	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-001	Sep 6, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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