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Last Updated: July 25, 2024

PILOCARPINE HYDROCHLORIDE - Generic Drug Details


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

Pilocarpine hydrochloride is the generic ingredient in six branded drugs marketed by 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 thirteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pilocarpine hydrochloride has fifty-five patent family members in twenty-four countries.

There are seven drug master file entries for pilocarpine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for PILOCARPINE HYDROCHLORIDE
International Patents:55
US Patents:5
Tradenames:6
Applicants:13
NDAs:13
Drug Master File Entries: 7
Finished Product Suppliers / Packagers: 14
Raw Ingredient (Bulk) Api Vendors: 74
Clinical Trials: 50
Patent Applications: 5,881
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in PILOCARPINE HYDROCHLORIDE?PILOCARPINE HYDROCHLORIDE excipients list
DailyMed Link:PILOCARPINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for PILOCARPINE HYDROCHLORIDE

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 HYDROCHLORIDE clinical trials

Pharmacology for PILOCARPINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PILOCARPINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VUITY Ophthalmic Solution pilocarpine hydrochloride 1.25% 214028 1 2022-12-30

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
Aurobindo Pharma Ltd PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 212377-001 Aug 13, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Innogenix PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 076963-001 Dec 22, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 214193-003 Sep 21, 2020 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie VUITY pilocarpine hydrochloride SOLUTION;OPHTHALMIC 214028-001 Oct 28, 2021 RX Yes Yes ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PILOCARPINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Mexico 2023003124 COMPOSICIONES FARMACEUTICAS OFTALMICAS Y USOS QUE SE RELACIONAN A LAS MISMAS. (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO.) ⤷  Sign Up
South Korea 20230079489 안구 증상의 치료를 위한 필로카르핀 염산염의 용도 (USE OF PILOCARPINE HYDROCHLORIDE FOR THE TREATMENT OF OCULAR CONDITIONS) ⤷  Sign Up
South Korea 102472774 ⤷  Sign Up
Poland 3681500 ⤷  Sign Up
Canada 3074618 TRAITEMENTS DE LA PRESBYTIE (PRESBYOPIA TREATMENTS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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