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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for pilocarpine hydrochloride

International Patents:	56
US Patents:	6
Tradenames:	6
Applicants:	13
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	50
Patent Applications:	5,881
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

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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
Somerset Theraps Llc	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	210384-001	Nov 25, 2019	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	077248-001	Mar 31, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	212377-002	Aug 13, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	212377-001	Aug 13, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Israel	297367	תכשירי רוקחות עיניים ושימושים הקשורים אליהם (Ophthalmic pharmaceutical compositions and uses relating thereto)	⤷ Sign Up
Brazil	112020021845	tratamentos para presbiopia	⤷ Sign Up
China	112272558	盐酸毛果芸香碱用于治疗眼部病症的用途 (PRESBYOPIA TREATMENTS)	⤷ Sign Up
Australia	2017311636		⤷ Sign Up
European Patent Office	3500255	COMPOSITIONS PHARMACEUTIQUES OPHTALMIQUES ET UTILISATIONS ASSOCIÉES (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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