List of Tasigna drug patents

Tasigna is owned by Novartis.

Tasigna contains Nilotinib Hydrochloride.

Tasigna has a total of 14 drug patents out of which 0 drug patents have expired.

Tasigna was authorised for market use on 29 October, 2007.

Tasigna is available in capsule;oral dosage forms.

Tasigna can be used as treatment of newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (ph + cml); treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml), a method for the treatment of leukemias, treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml), treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml); treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml) by administering nilotinib dispersed in a fruit preparation.

The generics of Tasigna are possible to be released after 07 October, 2032.

TASIGNA's oppositions filed in EPO
Patent Number Company Patent Title Patent Expiry Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7169791 NOVARTIS Inhibitors of tyrosine kinases
Jul, 2023

(3 months from now)

US8415363 NOVARTIS Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jul, 2026

(3 years from now)

US8163904 NOVARTIS Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Aug, 2028

(5 years from now)

US9061029 NOVARTIS Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Apr, 2032

(9 years from now)

These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7169791

(Pediatric)

NOVARTIS Inhibitors of tyrosine kinases
Jan, 2024

(9 months from now)

US8501760 NOVARTIS Pharmaceutical compositions comprising nilotinib or its salt
Jul, 2026

(3 years from now)

US8389537 NOVARTIS Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jul, 2026

(3 years from now)

US8415363

(Pediatric)

NOVARTIS Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jan, 2027

(3 years from now)

US8501760

(Pediatric)

NOVARTIS Pharmaceutical compositions comprising nilotinib or its salt
Jan, 2027

(3 years from now)

US8389537

(Pediatric)

NOVARTIS Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jan, 2027

(3 years from now)

US8293756 NOVARTIS Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Sep, 2027

(4 years from now)

US8293756

(Pediatric)

NOVARTIS Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Mar, 2028

(4 years from now)

US8163904

(Pediatric)

NOVARTIS Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Feb, 2029

(5 years from now)

US9061029

(Pediatric)

NOVARTIS Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Oct, 2032

(9 years from now)

Exclusivity Exclusivity Expiration
Orphan Drug Exclusivity (ODE) Sep 23, 2028
Pediatric Exclusivity (PED) Sep 22, 2025

Drugs and Companies using NILOTINIB HYDROCHLORIDE ingredient

Market Authorisation Date: 29 October, 2007

Treatment: Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml); A method for the treatment of leukemias; Treatment of newly diagnosed philadelphia chromosome positive chronic myeloid ...

Dosage: CAPSULE;ORAL

How can I launch a generic of TASIGNA before it's patent expiration?
More Information on Dosage

TASIGNA family patents

28

United States

18

European Union

12

Japan

11

Korea, Republic of

10

Australia

10

China

9

Spain

8

Russia

8

Poland

8

Canada

7

Taiwan, Province of China

6

Denmark

6

Hong Kong

6

Slovenia

6

Portugal

6

Cyprus

6

Peru

6

New Zealand

5

Israel

5

South Africa

5

Mexico

5

Argentina

5

Brazil

5

Croatia

5

Malaysia

5

Ecuador

4

Jordan

4

Morocco

4

Norway

4

Tunisia

3

Hungary

3

Colombia

3

Singapore

3

Guatemala

2

Austria

2

Cuba

2

San Marino

2

Chile

2

RS

2

United Kingdom

EA

2

EA

1

Lithuania

1

Philippines

1

Uruguay

1

Costa Rica

1

Germany

1

Honduras

1

Georgia

1

Ukraine

1

Nicaragua

1

ME

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