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Last Updated: May 20, 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-four 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:	54
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

Sponsor	Phase
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Maastricht University Medical Center	Phase 3
Ocuphire Pharma, Inc.	Phase 3

See all pilocarpine hydrochloride clinical trials

Pharmacology for pilocarpine hydrochloride

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Agonists Cholinergic Muscarinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for pilocarpine hydrochloride

N07AX	Other parasympathomimetics
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01EB	Parasympathomimetics
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Innogenix	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	076963-001	Dec 22, 2004	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
Sandoz	ISOPTO CARPINE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	200890-002	Jun 22, 2010	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	⤷ 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
>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

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Country	Patent Number	Title	Estimated Expiration
Portugal	3681500		⤷ 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
Japan	2023105147	眼科用医薬組成物及びそれに関する使用 (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO)	⤷ Try a Trial
China	109803652	眼科药物组合物及其相关用途 (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO)	⤷ Try a Trial
European Patent Office	3681500		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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