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Details for Patent: 8,097,653

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Which drugs does patent 8,097,653 protect, and when does it expire?

Patent 8,097,653 protects AMITIZA and is included in one NDA.

This patent has eighteen patent family members in fourteen countries.

Summary for Patent: 8,097,653

Title:	Dosage unit comprising a prostaglandin analog for treating constipation
Abstract:	A dosage unit for treating constipation in a human patient is described. The dosage unit of the invention comprises a halogenated prostaglandin analog and a pharmaceutically suitable excipient. The dosage unit relieves constipation without substantial side effects.
Inventor(s):	Ueno; Ryuji (Montgomery, MD), Patchen; Myra L. (Fairfax, VA)
Assignee:	Sucampo AG (Zug, CH)
Application Number:	10/293,516
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,097,653
Patent Claim Types: see list of patent claims	Use; Composition;

Drugs Protected by US Patent 8,097,653

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
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes						METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes						METHOD FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT

Non-Orange Book US Patents Family Members for Patent 8,097,653

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
8,389,542	Dosage unit comprising a prostaglandin analog for treating constipation

International Family Members for US Patent 8,097,653

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	037524
Argentina	098997
Austria	522218
Brazil	0214075