ALUNBRIG Drug Patent Profile
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Which patents cover Alunbrig, and what generic alternatives are available?
Alunbrig is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.
This drug has ninety patent family members in thirty-nine countries.
The generic ingredient in ALUNBRIG is brigatinib. One supplier is listed for this compound. Additional details are available on the brigatinib profile page.
DrugPatentWatch® Generic Entry Outlook for Alunbrig
Alunbrig was eligible for patent challenges on April 28, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 10, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for ALUNBRIG
International Patents: | 90 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 10 |
Patent Applications: | 1,541 |
Drug Prices: | Drug price information for ALUNBRIG |
What excipients (inactive ingredients) are in ALUNBRIG? | ALUNBRIG excipients list |
DailyMed Link: | ALUNBRIG at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALUNBRIG
Generic Entry Date for ALUNBRIG*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ALUNBRIG
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Intergroupe Francophone de Cancerologie Thoracique | Phase 2 |
Takeda | Phase 1/Phase 2 |
Princess Maxima Center for Pediatric Oncology | Phase 1/Phase 2 |
Pharmacology for ALUNBRIG
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A Inducers Tyrosine Kinase Inhibitors |
US Patents and Regulatory Information for ALUNBRIG
ALUNBRIG is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALUNBRIG is ⤷ Try for Free.
This potential generic entry date is based on patent 10,385,078.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ALUNBRIG | brigatinib | TABLET;ORAL | 208772-001 | Apr 28, 2017 | RX | Yes | No | 9,611,283 | ⤷ Try for Free | ⤷ Try for Free | ||||
Takeda Pharms Usa | ALUNBRIG | brigatinib | TABLET;ORAL | 208772-002 | Apr 28, 2017 | RX | Yes | No | 9,273,077 | ⤷ Try for Free | ⤷ Try for Free | ||||
Takeda Pharms Usa | ALUNBRIG | brigatinib | TABLET;ORAL | 208772-001 | Apr 28, 2017 | RX | Yes | No | 9,012,462 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Takeda Pharms Usa | ALUNBRIG | brigatinib | TABLET;ORAL | 208772-003 | Oct 2, 2017 | RX | Yes | Yes | 9,273,077 | ⤷ Try for Free | ⤷ Try for Free | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ALUNBRIG
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Takeda Pharma A/S | Alunbrig | brigatinib | EMEA/H/C/004248 Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib. |
Authorised | no | no | no | 2018-11-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ALUNBRIG
When does loss-of-exclusivity occur for ALUNBRIG?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15335950
Patent: Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl) phenyl]-N2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 65169
Patent: FORMES CRISTALLINES DE 5-CHLORO-N4-[2-(DIMETHYLPHOSPHORYL)PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL)PIPERIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE (CRYSTALLINE FORMS OF 5-CHLORO-N4-[2-(DIMETHYLPHOSPHORYL)PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL)PIPERIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 17000979
Patent: Formas cristalinas de 5-cloro-n4-[2-(dimetilfosforil)fenil]-n2-{2-metoxi-4-[4-(4-metilpiperazin-1-il)piperidin-1-il]pirimidina-2,4-diamina
Estimated Expiration: ⤷ Try for Free
China
Patent: 7108559
Patent: 5‑氯‑N4‑[2‑(二甲基磷酰基)苯基]‑N2‑{2‑甲氧基‑4‑[4‑(4‑甲基哌嗪‑1‑基)哌啶‑1‑基]嘧啶‑2,4‑二胺的晶形 (Crystalline forms of 5-chloro-n4-[-2-(dimethylphosphoryl) phenyl]-n2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine)
Estimated Expiration: ⤷ Try for Free
Patent: 1825717
Patent: 5-氯-N4-[2-(二甲基磷酰基)苯基]-N2-{2-甲氧基-4-[4-(4-甲基哌嗪-1-基)哌啶-1-基]苯基}嘧啶-2,4-二胺的晶形 (Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl) phenyl]-N2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine)
Estimated Expiration: ⤷ Try for Free
Patent: 1888368
Patent: 5-氯-N4-[2-(二甲基磷酰基)苯基]-N2-{2-甲氧基-4-[4-(4-甲基哌嗪-1-基)哌啶-1-基]苯基}嘧啶-2,4-二胺的晶形 (Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl) phenyl]-N2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine)
Estimated Expiration: ⤷ Try for Free
Colombia
Patent: 17004714
Patent: Formas cristalinas de 5-cloro-n4-[2-(dimetilfosforil)fenil]-n2-{2-metoxi-4-[4-(4-metilpiperazin-1-il)piperidin-1-il]pirimidina-2,4-diamina
Estimated Expiration: ⤷ Try for Free
Costa Rica
Patent: 170146
Patent: FORMAS CRISTALINAS DE 5-CLORO-N4-[-2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-YL)PIPERIDIN-1-IL]PIRIMIDINA-2,4-DIAMINA
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0201343
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 23295
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 09647
Estimated Expiration: ⤷ Try for Free
Dominican Republic
Patent: 017000101
Patent: FORMAS CRISTALINAS DE 5-CLORO-N4-[2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL]PIRIMIDINA-2,4-DIAMINA
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 17030878
Patent: FORMAS CRISTALINAS DE 5-CLORO-N4-[2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL]PIRIMIDINA-2,4-DIAMINA
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 5145
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 5-ХЛОР-N4-[2-(ДИМЕТИЛФОСФОРИЛ)ФЕНИЛ]-N2-{2-МЕТОКСИ-4-[4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)ПИПЕРИДИН-1-ИЛ]ФЕНИЛ}ПИРИМИДИН-2,4-ДИАМИНА (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL)PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL)PIPERIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Patent: 1790892
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 5-ХЛОР-N4-[2-(ДИМЕТИЛФОСФОРИЛ)ФЕНИЛ]-N2-{2-МЕТОКСИ-4-[4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)ПИПЕРИДИН-1-ИЛ]}ПИРИМИДИН-2,4-ДИАМИНА
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 09647
Patent: FORMES CRISTALLINES DE 5-CHLORO-N4- [-2- (DIMÉTHYLPHOSPHORYL) PHÉNYL]-N2- {2-MÉTHOXY-4- [4- (4-MÉTHYLPIPÉRAZIN-1-YL) PIPÉRIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Patent: 60618
Patent: FORMES CRISTALLINES DE 5-CHLORO-N4-[-2-(DIMÉTHYLPHOSPHORYL) PHÉNYL]-N2-{2-MÉTHOXY-4-[4-(4-MÉTHYLPIPERAZINE-1-YL) PIPÉRIDINE-1-YL]PYRIMIDINE-2,4-DIAMINE (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 51693
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 1818
Patent: צורות גבישיות של 5- כלורו-אן 4- [2-(דימתילפוספוריל)פניל]-אן2-{2-מתוקסי-4-[4-(4-מתילפיפראזין-1-איל) פיפרידין-1-איל]פירימידין-2-4-דיאמין (Crystalline forms of 5-chloro-n4-[2-(dimethylphosphoryl)phenyl]-n2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]pyrimidine-2,4-diamine)
Estimated Expiration: ⤷ Try for Free
Patent: 9910
Patent: צורות גבישיות של 5- כלורו-אן 4- [2-(דימתילפוספוריל)פניל]-אן2-{2-מתוקסי-4-[4-(4-מתילפיפראזין-1-איל) פיפרידין-1-איל]פירימידין-2-4-דיאמין (Crystalline forms of 5-chloro-n4-[2-(dimethylphosphoryl)phenyl]-n2- {2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}pyrimidine-2,4-diamine)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 33072
Estimated Expiration: ⤷ Try for Free
Patent: 17535538
Patent: 5−クロロ−N4−[2−(ジメチルホスホリル)フェニル]−N2−{2−メトキシ−4−[4−(4−メチルピペラジン−1−イル)ピペリジン−1−イル]ピリミジン−2,4−ジアミンの結晶形態
Estimated Expiration: ⤷ Try for Free
Patent: 20063276
Patent: 5−クロロ−N4−[2−(ジメチルホスホリル)フェニル]−N2−{2−メトキシ−4−[4−(4−メチルピペラジン−1−イル)ピペリジン−1−イル]フェニル}ピリミジン−2,4−ジアミンの結晶形態 (CRYSTAL FORM OF 5-CHLORO-N4-[2-(DIMETHYL PHOSPHORYL)PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZINE-1-YL)PIPERIDINE-1-YL]PHENYL}PYRIMIDINE-2,4-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 09647
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 2216
Patent: CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PYRIMIDINE-2,4-DIAMINE
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 17005120
Patent: FORMAS CRISTALINAS DE 5-CLORO-N4-[-2-(DIMETILFOSFORIL) FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL] PIRIMIDIN-2,4-DIAMINA. (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PYRIMIDINE-2,4-DIAMINE.)
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 0940
Patent: Crystalline forms of 5-chloro-n4-[-2-(dimethylphosphoryl) phenyl]-n2-{ 2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 171344
Patent: FORMAS CRISTALINAS DE 5-CLORO-N4-[2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL]PIRIMIDINA-2,4-DIAMINA
Estimated Expiration: ⤷ Try for Free
Philippines
Patent: 017500732
Patent: CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PYRIMIDINE-2,4-DIAMINE
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 09647
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 737
Patent: KRISTALNI OBLICI 5-HLORO-N4-[-2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOKSI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL]PIRIMIDIN-2,4-DIAMINA (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 201702980Q
Patent: CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PYRIMIDINE-2,4-DIAMINE
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 09647
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1702737
Patent: CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PHENYL}PYRIMIDINE-2,4-DIAMINE
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2331856
Estimated Expiration: ⤷ Try for Free
Patent: 170072905
Patent: 결정 형태의 5-클로로-N4-[2-페닐]-N2-{2-메톡시-4-[4-피페리딘-1-일]피리미딘-2,4-디아민 (5--N4-[2-]-N2-2--4-[4-4--1--1-]-24-CRYSTALLINE FORMS OF 5-CHLORO-N4-[2-DIMETHYLPHOSPHORYLPHENYL]-N2-2-METHOXY-4-[4-4-METHYLPIPERAZIN-1-YLPIPERIDIN-1-YL]PYRIMIDINE-24-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Patent: 210142781
Patent: 결정 형태의 5-클로로-N4-[2-페닐]-N2-{2-메톡시-4-[4-피페리딘-1-일]피리미딘-2,4-디아민 (5--N4-[2-]-N2-2--4-[4-4--1--1-]-24-CRYSTALLINE FORMS OF 5-CHLORO-N4-[2-DIMETHYLPHOSPHORYLPHENYL]-N2-2-METHOXY-4-[4-4-METHYLPIPERAZIN-1-YLPIPERIDIN-1-YL]PYRIMIDINE-24-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 13726
Estimated Expiration: ⤷ Try for Free
Tunisia
Patent: 17000157
Patent: CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PYRIMIDINE-2,4-DIAMINE
Estimated Expiration: ⤷ Try for Free
Ukraine
Patent: 9794
Patent: КРИСТАЛІЧНА ФОРМА 5-ХЛОР-N4-[2-(ДИМЕТИЛФОСФОРИЛ)ФЕНІЛ]-N2-{2-МЕТОКСИ-4-[4-(4-МЕТИЛПІПЕРАЗИН-1-ІЛ)ПІПЕРИДИН-1-ІЛ]}ПІРИМІДИН-2,4-ДІАМІНУ (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PYRIMIDINE-2,4-DIAMINE)
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ALUNBRIG around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 2300013 | ⤷ Try for Free | |
Croatia | P20171534 | ⤷ Try for Free | |
Lithuania | C2300013 | ⤷ Try for Free | |
South Korea | 20110010801 | PHOSPHOROUS DERIVATIVES AS KINASE INHIBITORS | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALUNBRIG
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2300013 | 132019000000069 | Italy | ⤷ Try for Free | PRODUCT NAME: BRIGATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ALUNBRIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1264, 20181126 |
2300013 | 31/2019 | Austria | ⤷ Try for Free | PRODUCT NAME: BRIGATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 (MITTEILUNG) 20181126 |
2300013 | PA2019510 | Lithuania | ⤷ Try for Free | PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122 |
2300013 | 363 50014-2019 | Slovakia | ⤷ Try for Free | OWNER(S): TAKEDA PHARMACEUTICAL COMPANY LIMITED, CHUO-KU, OSAKA-SHI, OSAKA, JP; PREDCHADZAJUCI MAJITEL: DYAX CORP., LEXINGTON, MA, US; DATUM ZAPISU DO REGISTRA: 4.4.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for ALUNBRIG
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