Pralsetinib - Generic Drug Details

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What are the generic sources for pralsetinib and what is the scope of patent protection?

Pralsetinib is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pralsetinib has forty-seven patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for pralsetinib

International Patents:	47
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Patent Applications:	82
What excipients (inactive ingredients) are in pralsetinib?	pralsetinib excipients list
DailyMed Link:	pralsetinib at DailyMed

Recent Clinical Trials for pralsetinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hoffmann-La Roche	Phase 2
Genentech, Inc.	Phase 2
Blueprint Medicines Corporation	Phase 2

See all pralsetinib clinical trials

Pharmacology for pralsetinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Rearranged during Transfection (RET) Inhibitors

US Patents and Regulatory Information for pralsetinib

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech Inc	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Genentech Inc	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Genentech Inc	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Genentech Inc	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Genentech Inc	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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 pralsetinib

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Gavreto	pralsetinib	EMEA/H/C/005413 Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.	Authorised	no	no	no	2021-11-18
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for pralsetinib

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3371171	INHIBITEURS DE RET (INHIBITORS OF RET)	See Plans and Pricing
Russian Federation	2020135917	ИНГИБИТОР RET ДЛЯ ПРИМЕНЕНИЯ В ЛЕЧЕНИИ РАКА, ИМЕЮЩЕГО RET-АЛЬТЕРАЦИЮ	See Plans and Pricing
Mexico	2018005528	INHIBIDORES DE RET. (INHIBITORS OF RET.)	See Plans and Pricing
Israel	258902	מעכבים של ret (Inhibitors of ret)	See Plans and Pricing
Canada	3003721	INHIBITEURS DE RET (INHIBITORS OF RET)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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