PRILOCAINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for prilocaine hydrochloride and what is the scope of patent protection?

Prilocaine hydrochloride is the generic ingredient in four branded drugs marketed by Astrazeneca, Dentsply Pharm, and Septodont Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for prilocaine hydrochloride. One supplier is listed for this compound.

Summary for PRILOCAINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	108
Patent Applications:	350
What excipients (inactive ingredients) are in PRILOCAINE HYDROCHLORIDE?	PRILOCAINE HYDROCHLORIDE excipients list
DailyMed Link:	PRILOCAINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PRILOCAINE HYDROCHLORIDE

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

Sponsor	Phase
Assiut University	N/A
Universitas Sebelas Maret	Phase 4
Indonesia Endowment Fund for Education	Phase 4

See all PRILOCAINE HYDROCHLORIDE clinical trials

Pharmacology for PRILOCAINE HYDROCHLORIDE

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for PRILOCAINE HYDROCHLORIDE

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for PRILOCAINE HYDROCHLORIDE

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for PRILOCAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CITANEST	prilocaine hydrochloride	INJECTABLE;INJECTION	014763-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Dentsply Pharm	CITANEST PLAIN DENTAL	prilocaine hydrochloride	INJECTABLE;INJECTION	021382-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	CITANEST PLAIN	prilocaine hydrochloride	INJECTABLE;INJECTION	014763-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	CITANEST	prilocaine hydrochloride	INJECTABLE;INJECTION	014763-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	CITANEST	prilocaine hydrochloride	INJECTABLE;INJECTION	014763-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No