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Details for Patent: 6,866,866

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Which drugs does patent 6,866,866 protect, and when does it expire?

Patent 6,866,866 protects ACTOPLUS MET XR and FORTAMET and is included in two NDAs.

This patent has fifteen patent family members in nine countries.

Summary for Patent: 6,866,866

Title:	Controlled release metformin compositions
Abstract:	A composition for treating patients having non-insulin-dependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug such as metformin, on a once-a-day basis. The dosage form provides a mean time to maximum plasma concentration (T.sub.max) of the drug which occurs at 5.5 to 7.5 hours after oral administration on a once-a-day basis to human patients. Preferably, the dose of drug is administered at dinnertime to a patient in the fed state.
Inventor(s):	Chen; Chih-Ming (Davie, FL), Cheng; Xiu-Xiu (Davie, FL), Jan; Steve (Coral Springs, FL), Chou; Joseph (Manassas, VA)
Assignee:	Andrx Labs, LLC (Davie, FL)
Application Number:	09/705,630
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Formulation; Device;

Drugs Protected by US Patent 6,866,866

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		RX	Yes	No			Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		RX	Yes	Yes			Y
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	AB2	RX	Yes	Yes			Y
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	AB2	RX	Yes	No			Y

Non-Orange Book US Patents Family Members for Patent 6,866,866

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,790,459	Methods for treating diabetes via administration of controlled release metformin

International Patents Family Members for US Patent 6,866,866

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
New Zealand	525559
Mexico	PA03003994
South Korea	20030061392
Japan	2007535557