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Last Updated: March 29, 2024

Pilocarpine hydrochloride - Generic Drug Details


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What are the generic 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-three 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:53
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
Maastricht University Medical CenterPhase 3
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 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
Orasis Pharms QLOSI pilocarpine hydrochloride SOLUTION;OPHTHALMIC 217836-001 Oct 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077220-002 May 6, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 212377-002 Aug 13, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Somerset Theraps Llc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 210384-001 Nov 25, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 204398-002 Sep 27, 2017 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie VUITY pilocarpine hydrochloride SOLUTION;OPHTHALMIC 214028-001 Oct 28, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alcon PILOPINE HS pilocarpine hydrochloride GEL;OPHTHALMIC 018796-001 Oct 1, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 3681500 ⤷  Try a Trial
Slovenia 3681500 ⤷  Try a Trial
Hungary E058931 ⤷  Try a Trial
Mexico 2020011301 USO DE CLORHIDRATO DE PILOCARPINA PARA EL TRATAMIENTO DE AFECCIONES OCULARES. (USE OF PILOCARPINE HYDROCHLORIDE FOR THE TREATMENT OF OCULAR CONDITIONS.) ⤷  Try a Trial
China 112272558 盐酸毛果芸香碱用于治疗眼部病症的用途 (PRESBYOPIA TREATMENTS) ⤷  Try a Trial
Canada 3031370 COMPOSITIONS PHARMACEUTIQUES OPHTALMIQUES ET UTILISATIONS ASSOCIEES (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO) ⤷  Try a Trial
Canada 3162141 TRAITEMENTS DE LA PRESBYTIE (PRESBYOPIA TREATMENTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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