Claims for Patent: 9,248,115

Summary for Patent: 9,248,115

Title:	Silibinin component for the treatment of hepatitis
Abstract:	The invention relates to the use of a silibinin component for the production of a medicament that is adapted for parenteral administration for the treatment of viral hepatitis, preferably of hepatitis B or C, in particular for the reduction of the virus load. The medicament preferably contains no silidianin and/or no silichristin and/or no isosilibinin.
Inventor(s):	Rovati; Lucio Claudio (Monza, IT), D\'Amato; Massimo Maria (Monza, IT), Mengs; Ulrich (Roesrath, DE), Pohl; Ralf-Torsten (Speyer, DE), Ferenci; Peter (Vienna, AU)
Assignee:	MADAUS GMBH (Cologne, DE)
Application Number:	13/871,045
Patent Claims:	1. A method of treating hepatitis C comprising intravenously administering to a subject in need thereof a medicament comprising silibinin C2',3-bis(hydrogensuccinate) or a physiologically acceptable salt thereof as a silibinin component, wherein the medicament contains the silibinin component in a dose of at least 20 mg/kg, based on the body weight of the patient as an equivalent dose based on silibinin, and wherein the medicament essentially contains no silidianin, no silicristin, and no isosilibinin. 2. The method according to claim 1, wherein the medicament contains no other constituent of silymarin besides the silibinin component. 3. The method according to claim 1, wherein the medicament contains the silibinin component in a dose of at least 50 mg/kg, based on the body weight of the patient as an equivalent dose based on silibinin. 4. The method according to claim 1, wherein the medicament comprises a further pharmaceutical in addition to the silibinin component. 5. The method according to claim 4, wherein the further pharmaceutical is selected from the group consisting of arginine glutamate, citiolone, epomediol, ornithine oxoglurate, tidiacicarginine, myoinositol, methionine and N-acetylmethionine, choline, ornithine aspartate, cianidanol, tiopronine, betaine, cyanocobalamin, leucine, levulose, aciclovir, idoxuridine, vidarabine, ribavirin, ganciclovir, famciclovir, valaciclovir, cidofovir, penciclovir, valganciclovir, brivudine, interferon alfa, interferon beta, interferon gamma, interferon alfa-2a, interferon alfa-2b, interferon alfa-n1, interferon beta-1a, interferon beta-1b, interferon alfacon-1, peginterferon alfa-2b, peginterferon alfa-2a and interferon gamma 1b. 6. The method according to claim 1, wherein the medicament is administered to reduce the viral load in hepatitis patients. 7. The method according to claim 1, wherein the medicament is administered to treat viral hepatitis in a patient who will undergo or has undergone liver transplantation. 8. The method according to claim 1, wherein the medicament is administered to treat viral hepatitis in a patient who does not respond to therapy comprising ribavirin plus interferon. 9. The method according to claim 1, wherein after administering the medicament, another pharmaceutical is administered to the subject in need thereof. 10. The method according to claim 1, wherein the medicament is administered as a part of a sequential treatment, where the medicament is initially administered for a first period, and subsequently another pharmaceutical is administered for a second period. 11. The method according to claim 10, wherein the first period comprises at least 2 days. 12. The method as claimed in claim 9, wherein the pharmaceutical is selected from the group consisting of arginine glutamate, silymarin, citiolone, epomediol, ornithine oxoglurate, tidiacicarginine, myoinositol, methionine and N-acetylmethionine, choline, ornithine aspartate, cianidanol, tiopronine, betaine, cyanocobalamin, leucine, levulose, aciclovir, idoxuridine, vidarabine, ribavirin, ganciclovir, famciclovir, valaciclovir, cidofovir, penciclovir, valganciclovir, brivudine, interferon alfa, interferon beta, interferon gamma, interferon alfa-2a, interferon alfa-2b, interferon alfa-n1, interferon beta-1a, interferon beta-1b, interferon alfacon-1, peginterferon alfa-2b, peginterferon alfa-2a and interferon gamma 1b. 13. The method according to claim 9, wherein the pharmaceutical is administered orally to the subject in need thereof.

Details for Patent 9,248,115

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2027-11-15
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2027-11-15
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2027-11-15
Hoffmann-la Roche Inc.	ROFERON-A	interferon alfa-2a	For Injection	103145	06/04/1986		2027-11-15
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471	07/23/1993		2027-11-15