PILOCARPINE HYDROCHLORIDE Drug Patent Profile

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

Pilocarpine Hydrochloride is a drug marketed by Amneal, Rising, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us. and is included in eight NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pilocarpine Hydrochloride

A generic version of PILOCARPINE HYDROCHLORIDE was approved as pilocarpine hydrochloride by PADAGIS US on November 16^th, 2004.

Summary for PILOCARPINE HYDROCHLORIDE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	50
Patent Applications:	3,807
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
Maastricht University Medical Center	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	214193-001	Sep 21, 2020	AT	RX	No	No
Padagis Us	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	076746-001	Nov 16, 2004	AB	RX	No	No
Somerset Theraps Llc	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	210384-001	Nov 25, 2019	AT	RX	No	No
Rising	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	204398-001	Sep 27, 2017	AT	RX	No	No
Impax Labs	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	077248-001	Mar 31, 2006	AB	RX	No	No
Somerset Theraps Llc	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	210384-002	Nov 25, 2019	AT	RX	No	No
Lannett Co Inc	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	077220-001	Oct 14, 2005	AB	RX	No	No