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Last Updated: September 24, 2020

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PILOCARPINE HYDROCHLORIDE Drug Profile

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When do Pilocarpine Hydrochloride patents expire, and what generic alternatives are available?

Pilocarpine Hydrochloride is a drug marketed by Akorn Inc, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Perrigo Pharma Intl. and is included in seven NDAs.

The generic ingredient in PILOCARPINE HYDROCHLORIDE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Pilocarpine Hydrochloride

A generic version of PILOCARPINE HYDROCHLORIDE was approved as pilocarpine hydrochloride by PERRIGO PHARMA INTL on November 16th, 2004.

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Drug patent expirations by year for PILOCARPINE HYDROCHLORIDE
Recent Clinical Trials for PILOCARPINE HYDROCHLORIDE

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SponsorPhase
Universidad de MurciaPhase 1
Montefiore Medical CenterPhase 3
Maastricht University Medical CenterEarly Phase 1

See all PILOCARPINE HYDROCHLORIDE clinical trials

Pharmacology for PILOCARPINE HYDROCHLORIDE

US Patents and Regulatory Information for PILOCARPINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn Inc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 204398-001 Sep 27, 2017 AT RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 212377-001 Aug 13, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Somerset Theraps Llc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 210384-001 Nov 25, 2019 AT RX No No   Start Trial   Start Trial   Start Trial
Innogenix PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 076963-002 Feb 27, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 212377-002 Aug 13, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077220-002 May 6, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 204398-002 Sep 27, 2017 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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