Alectinib hydrochloride - Generic Drug Details
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What are the generic drug sources for alectinib hydrochloride and what is the scope of freedom to operate?
Alectinib hydrochloride
is the generic ingredient in one branded drug marketed by Hoffmann-la Roche and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Alectinib hydrochloride has one hundred and thirty-seven patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for alectinib hydrochloride
International Patents: | 137 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 62 |
Patent Applications: | 69 |
What excipients (inactive ingredients) are in alectinib hydrochloride? | alectinib hydrochloride excipients list |
DailyMed Link: | alectinib hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for alectinib hydrochloride
Generic Entry Date for alectinib hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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 alectinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hunan Province Tumor Hospital | Phase 1/Phase 2 |
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Phase 2/Phase 3 |
Joshua Palmer | Phase 1/Phase 2 |
Pharmacology for alectinib hydrochloride
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for alectinib hydrochloride
Paragraph IV (Patent) Challenges for ALECTINIB HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ALECENSA | Capsules | alectinib hydrochloride | 150 mg | 208434 | 1 | 2019-12-11 |
US Patents and Regulatory Information for alectinib hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Hoffmann-la Roche | ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434-001 | Dec 11, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ 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 |
International Patents for alectinib hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E046402 | ⤷ Try for Free | |
China | 113975243 | ⤷ Try for Free | |
South Africa | 201606447 | PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for alectinib hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2441753 | PA2017017,C2441753 | Lithuania | ⤷ Try for Free | PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216 |
2441753 | 31/2017 | Austria | ⤷ Try for Free | PRODUCT NAME: ALECTINIB ODER DESSEN SALZE ODER DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/16/1169 20170220 |
2441753 | 1790024-2 | Sweden | ⤷ Try for Free | PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/16/1169/001 20170220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Alectinib Hydrochloride
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