Erleada is owned by Janssen Biotech.
Erleada contains Apalutamide.
Erleada has a total of 9 drug patents out of which 0 drug patents have expired.
Erleada was authorised for market use on 14 February, 2018.
Erleada is available in tablet;oral dosage forms.
Erleada can be used as treatment of non-metastatic, castration-resistant prostate cancer (nm-crpc); treatment of metastatic castration-sensitive prostate cancer (mcspc), treatment in combination with a gnrh agonist of non-metastatic, castration-resistant prostate cancer (nm-crpc); treatment in combination with a gnrh agonist of high risk non-metastatic, castration-resistant prostate cancer (nm-crpc), treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (nmcrpc) that improves metastasis free survival, treatment of non-metastatic, castration-resistant prostate cancer (nm-crpc), treatment in combination with orchiectomy of non-metastatic, castration-resistant prostate cancer (nmcrpc), treatment of metastatic castration-sensitive prostate cancer (mcspc); treatment of non-metastatic, castration-resistant prostate cancer (nm-crpc).
Drug patent challenges can be filed against Erleada from February, 2022.
The generics of Erleada are possible to be released after 30 April, 2038.
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. | ||||
US9388159 | JANSSEN BIOTECH | Substituted diazaspiroalkanes as androgen receptor modulators |
Mar, 2027
(4 years from now) | |
US8445507 | JANSSEN BIOTECH | Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases |
Sep, 2030
(7 years from now) | |
US9481663 | JANSSEN BIOTECH | Crystalline forms of an androgen receptor modulator |
Jun, 2033
(10 years from now) | |
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
US9987261 | JANSSEN BIOTECH | Substituted diazaspiroalkanes as androgen receptor modulators |
Mar, 2027
(4 years from now) | |
US8802689 | JANSSEN BIOTECH | Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases |
Mar, 2027
(4 years from now) | |
US9884054 | JANSSEN BIOTECH | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
Sep, 2033
(10 years from now) | |
US10849888 | JANSSEN BIOTECH | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
Sep, 2033
(10 years from now) | |
US10052314 | JANSSEN BIOTECH | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
Sep, 2033
(10 years from now) | |
US10702508 | JANSSEN BIOTECH | Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer |
Apr, 2038
(15 years from now) |
Exclusivity | Exclusivity Expiration |
---|---|
New Chemical Entity Exclusivity (NCE) | Feb 14, 2023 |
New Indication (I) | Sep 17, 2022 |
Drugs and Companies using APALUTAMIDE ingredient
NCE-1 date: February, 2022
Market Authorisation Date: 14 February, 2018
Treatment: Treatment of non-metastatic, castration-resistant prostate cancer (nm-crpc); Treatment of metastatic castration-sensitive prostate cancer (mcspc); Treatment in combination with orchiectomy of non-metastatic, castration-resistant prostate cancer (nmcrpc); Treatment in combination with a gnrh agonist of non-metastatic, castration-resistant prostate cancer (nm-crpc); Treatment in combination with a gnrh agonist of high risk non-metastatic, castration-resistant prostate cancer (nm-crpc); Treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (nmcrpc) that improves metastasis free survival
Dosage: TABLET;ORAL
39
United States
18
Japan
15
European Union
11
Hungary
10
Lithuania
10
Spain
10
Slovenia
10
Denmark
9
Poland
9
Portugal
8
Hong Kong
8
Australia
8
China
7
Singapore
7
EA
7
Philippines
6
Korea, Republic of
6
Cyprus
6
New Zealand
6
Canada
4
RS
4
Brazil
4
Ukraine
4
Israel
4
Croatia
3
Mexico
3
Peru
3
Costa Rica
2
Chile
2
Malaysia
2
Guatemala
2
South Africa
2
ME
2
Nicaragua
2
India
2
Taiwan, Province of China
2
Ecuador
1
Luxembourg
1
Jordan
1
Netherlands
1
Argentina
1
Colombia
1
Turkey
1
Norway
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