PRALSETINIB - Generic Drug Details

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What are the generic drug sources for pralsetinib and what is the scope of freedom to operate?

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

Pralsetinib has seventy-eight patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for PRALSETINIB

International Patents:	78
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	7
Patent Applications:	89
What excipients (inactive ingredients) are in PRALSETINIB?	PRALSETINIB excipients list
DailyMed Link:	PRALSETINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PRALSETINIB

Generic Entry Date for PRALSETINIB^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 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

Anatomical Therapeutic Chemical (ATC) Classes for PRALSETINIB

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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)	⤷ Sign Up
European Patent Office	3773589	INHIBITEUR DE RET DESTINÉ À ÊTRE UTILISÉ DANS LE TRAITEMENT DU CANCER PRÉSENTANT UNE ALTÉRATION DU RET (RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION)	⤷ Sign Up
European Patent Office	4331585	INHIBITEURS DE RET (INHIBITORS OF RET)	⤷ Sign Up
Lithuania	3773589		⤷ Sign Up
Ecuador	SP18041935	INHIBIDORES DE RET	⤷ Sign Up
Japan	6807385		⤷ Sign Up
Finland	3371171		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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