Last Updated: September 24, 2026

Pilocarpine - Generic Drug Details


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

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

Summary for pilocarpine
Drug Prices for pilocarpine

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Recent Clinical Trials for pilocarpine

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

SponsorPhase
Southern College of OptometryPHASE4
Mansoura UniversityNA
Novus Vision LLCEARLY_PHASE1

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
Lannett Co Inc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077220-001 Oct 14, 2005 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION/DROPS;OPHTHALMIC 214193-003 Sep 21, 2020 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie VUITY pilocarpine hydrochloride SOLUTION/DROPS;OPHTHALMIC 214028-001 Oct 28, 2021 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Impax Labs PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077248-002 Mar 31, 2006 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Innogenix PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 076963-001 Dec 22, 2004 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION/DROPS;OPHTHALMIC 217733-001 Apr 28, 2025 RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Somerset Theraps Llc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION/DROPS;OPHTHALMIC 210384-002 Nov 25, 2019 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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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