ORAL DOSAGE FORMS COMPRISING PROGESTERONE AND METHOD OF MAKING AND USING THE SAME

(19)

(11)

EP 1 893 182 B8

(12)	CORRECTED EUROPEAN PATENT SPECIFICATION
	Note: Bibliography reflects the latest situation

(15)	Correction information:
	Corrected version no 1 (W1 B1)

(48)	Corrigendum issued on:
	04.04.2012 Bulletin 2012/14

(45)	Mention of the grant of the patent:
	01.02.2012 Bulletin 2012/05

(21)	Application number: 06771398.2

(22)	Date of filing: 26.05.2006

(51)

International Patent Classification (IPC):

A61K 9/48^(2006.01)
A61P 15/00^(2006.01)

A61K 9/16^(2006.01)
A61P 5/00^(2006.01)

(86)	International application number:
	PCT/US2006/020609

(87)	International publication number:
	WO 2006/128057 (30.11.2006 Gazette 2006/48)

(54)	ORAL DOSAGE FORMS COMPRISING PROGESTERONE AND METHOD OF MAKING AND USING THE SAME ORALE DOSIERFORMEN MIT PROGESTERON UND VERWENDUNGS- UND HERSTELLUNGSVERFAHREN DAFÜR FORMES POSOLOGIQUES ORALES CONTENANT DE LA PROGESTERONE ET PROCEDE DE FABRICATION ET D'UTILISATION DESDITES FORMES POSOLOGIQUES

(84)	Designated Contracting States:
	AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR
	Designated Extension States:
	AL BA HR MK YU

(30)

Priority:

26.05.2005 US 684557 P

(43)	Date of publication of application:
	05.03.2008 Bulletin 2008/10

(73)	Proprietor: Teva Women's Health, Inc.
	Woodcliff Lake, NJ 07677 (US)

(72)	Inventors:
	AHMED, Salah, U. New City, NY 10956 (US) DILIBERTI, Charles, E. Montclair, NJ 07043 (US) VATTIKONDA, Chandra Towaco, NJ 07082 (US) GORUKANTI, Sudhir, R. Harriman, NY 10926 (US) GUPTA, Sanjeev, K. Washington Township, NJ 07676 (US)

(74)	Representative: Clarke, Lionel Paul et al
	Gill Jennings & Every LLP The Broadgate Tower 20 Primrose Street London EC2A 2ES London EC2A 2ES (GB)

(56)

References cited: :

WO-A-91/18613
US-A- 4 963 540
US-A1- 2005 008 704

FR-A- 2 851 918
US-A- 5 620 705

SOLVAY: " Prometrium"19 pages, June 2009, information sheet for compliance with FDA regulations
"Handbook of pharmaceutical excipients, third edition", 2000, Pharmaceutical Press et al. page 651,
WIKIPEDIA: 'Excipient', [Online] pages 1 - 4 Retrieved from the Internet: <URL:http://en.wikipedia.org/w/index.php?ti tle=Excipient&printable=yes> [retrieved on 2010-07-09]
MENTIONS LÉGALES: 'Utrogestan', [Online] pages 1 - 3 Retrieved from the Internet: <URL:http://pro.gyneweb.fr/sources/industri e/labo/besins/utrogestan.html> [retrieved on 2010-07-09]
j.c. chaumeil: "Micronization: a method of improving the bioavailability of poorly soluble drugs", , 1998, page PAGE 1, Retrieved from the Internet: URL:http://journals.prous.com/journals/ser vlet/xmlxsl/pk_journals.xml_summary_pr?p_J ournal... [retrieved on 2011-03-17]

Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).