Generic Alecensa Availability
Last updated on Apr 10, 2025.
Alecensa is a brand name of alectinib, approved by the FDA in the following formulation(s):
ALECENSA (alectinib hydrochloride - capsule;oral)
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Manufacturer: HOFFMANN-LA ROCHE
Approval date: December 11, 2015
Strength(s): EQ 150MG BASE [RLD]
Is there a generic version of Alecensa available?
No. There is currently no therapeutically equivalent version of Alecensa available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Alecensa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Preparation containing tetracyclic compound at high dose
Patent 10,350,214
Issued: July 16, 2019
Inventor(s): Tomimatsu Takashi & Okazaki Kensuke & Ogawa Yumi & Yamamura Takahiro
Assignee(s): CHUGAI SEIYAKU KABUSHIKI KAISHAAn improved solubility of a pharmaceutical composition or formulation containing a large amount of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof can be achieved by forming granules of the compound or salt thereof and allowing the granules to be present together with a disintegrating agent.
Patent expiration dates:
- April 24, 2035✓
- April 24, 2035
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Preparation containing tetracyclic compound at high dose
Patent 11,433,076
Issued: September 6, 2022
Inventor(s): Tomimatsu Takashi & Okazaki Kensuke & Ogawa Yumi & Yamamura Takahiro
Assignee(s): Chugai Seiyaku Kabushiki KaishaAn improved solubility of a pharmaceutical composition or formulation containing a large amount of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof can be achieved by forming granules of the compound or salt thereof and allowing the granules to be present together with a disintegrating agent.
Patent expiration dates:
- April 24, 2035✓
- April 24, 2035
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Tetracyclic compound
Patent 9,126,931
Issued: September 8, 2015
Inventor(s): Kinoshita Kazutomo & Asoh Kohsuke & Furuichi Noriyuki & Ito Toshiya & Kawada Hatsuo & Ishii Nobuya & Sakamoto Hiroshi & Hong WooSang & Park MinJeong & Ono Yoshiyuki & Kato Yasuharu & Morikami Kenji & Emura Takashi & Oikawa Nobuhiro
Assignee(s): Chugai Seiyaku Kabushiki KaishaA compound represented by the general Formula (I) below, or a salt or solvate thereof, which is useful as an ALK inhibitor, and is useful for prophylaxis or treatment of a disease accompanied by abnormality in ALK, for example, cancer, cancer metastasis, depression or cognitive function disorder:
Patent expiration dates:
- May 29, 2031✓
- May 29, 2031
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Composition comprising tetracyclic compound
Patent 9,365,514
Issued: June 14, 2016
Inventor(s): Furumoto Kentaro & Shiraki Koji & Hirayama Tomoaki
Assignee(s): Chugai Seiyaku Kabushiki KaishaA composition which comprises substance represented by Formula (I),
Patent expiration dates:
- March 4, 2032✓
- March 4, 2032
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Tetracyclic compound
Patent 9,440,922
Issued: September 13, 2016
Inventor(s): Kinoshita Kazutomo & Asoh Kohsuke & Furuichi Noriyuki & Ito Toshiya & Kawada Hatsuo & Ishii Nobuya & Sakamoto Hiroshi & Hong WooSang & Park MinJeong & Ono Yoshiyuki & Kato Yasuharu & Morikami Kenji & Emura Takashi & Oikawa Nobuhiro
Assignee(s): Chugai Seiyaku Kabushiki KaishaA compound represented by the general Formula (I) below, or a salt or solvate thereof, which is useful as an ALK inhibitor, and is useful for prophylaxis or treatment of a disease accompanied by abnormality in ALK, for example, cancer, cancer metastasis, depression or cognitive function disorder:
Patent expiration dates:
- June 9, 2030✓
- June 9, 2030
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- April 18, 2027 - FOR ADJUVANT TREATMENT IN ADULT PATIENTS FOLLOWING TUMOR RESECTION OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) (TUMORS >/= 4 CM OR NODE POSITIVE), AS DETECTED BY AN FDA-APPROVED TEST
- April 18, 2031 - ADJUVANT TREATMENT IN ADULT PATIENTS FOLLOWING TUMOR RESECTION OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) (TUMORS GREATER THAN OR EQUAL TO 4 CM OR NODE POSITIVE), AS DETECTED BY AN FDA-APPROVED TEST
More about Alecensa (alectinib)
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- Reviews (2)
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- Side effects
- Dosage information
- Patient tips
- During pregnancy
- FDA approval history
- Drug class: multikinase inhibitors
- Breastfeeding
- En español
Patient resources
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.