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Last Updated: November 4, 2024

PILOCARPINE - Generic Drug Details


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

Pilocarpine is the generic ingredient in eight branded drugs marketed by Epic Pharma Llc, Alcon, Sandoz, Amneal, Rising, Somerset Theraps Llc, Orasis Pharms, Abbvie, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, Padagis Us, and Concordia, and is included in fifteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for pilocarpine.

Drug Prices for PILOCARPINE

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Recent Clinical Trials for PILOCARPINE

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

SponsorPhase
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3
Maastricht University Medical CenterPhase 3
Ocuphire Pharma, Inc.Phase 3

See all PILOCARPINE clinical trials

Medical Subject Heading (MeSH) Categories for PILOCARPINE

US Patents and Regulatory Information for PILOCARPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Us PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 076746-001 Nov 16, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Somerset Theraps Llc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 210384-001 Nov 25, 2019 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Somerset Theraps Llc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 210384-002 Nov 25, 2019 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 214193-001 Sep 21, 2020 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lannett Co Inc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077220-002 May 6, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Orasis Pharms QLOSI pilocarpine hydrochloride SOLUTION;OPHTHALMIC 217836-001 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up 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

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