Proparacaine hydrochloride - Generic Drug Details

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What are the generic sources for proparacaine hydrochloride and what is the scope of freedom to operate?

Proparacaine hydrochloride is the generic ingredient in six branded drugs marketed by Alcon Labs Inc, Pharmafair, Apothecon, Allergan, Optopics, Bausch And Lomb, Rising, Sola Barnes Hind, and Somerset Theraps Llc, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for proparacaine hydrochloride. Six suppliers are listed for this compound.

Sponsor

Phase

American Genomics, LLC

Phase 3

Prisma Health-Upstate

Phase 4

Vishal Jhanji

Phase 4

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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
Allergan	OPHTHETIC	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	012583-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sola Barnes Hind	PROPARACAINE HYDROCHLORIDE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	084151-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch And Lomb	PROPARACAINE HYDROCHLORIDE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040074-001	Sep 29, 1995	AT	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmafair	KAINAIR	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	088087-001	Jun 7, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	PROPARACAINE HYDROCHLORIDE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	215816-001	Aug 9, 2024	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	6
Applicants:	9
NDAs:	10
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	30
Patent Applications:	1,140
What excipients (inactive ingredients) are in proparacaine hydrochloride?	proparacaine hydrochloride excipients list
DailyMed Link:	proparacaine hydrochloride at DailyMed

Drug Class	Local Anesthetic
Physiological Effect	Local Anesthesia