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Last Updated: April 19, 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

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

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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Innogenix	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	076963-002	Feb 27, 2007	AB	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
Aurobindo Pharma Ltd	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	212377-001	Aug 13, 2019	AB	RX	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

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Country	Patent Number	Title	Estimated Expiration
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
South Korea	20220162876	안과용 약학 조성물 및 이와 관련된 용도 (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO)	⤷ Try a Trial
Australia	2023226732	Ophthalmic pharmaceutical compositions and uses relating thereto	⤷ Try a Trial
Russian Federation	2019107585	ОФТАЛЬМОЛОГИЧЕСКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И ИХ ПРИМЕНЕНИЕ	⤷ Try a Trial
Portugal	3681500		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.