Pilocarpine - Generic Drug Details

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What are the generic drug sources for pilocarpine and what is the scope of freedom to operate?

Pilocarpine is the generic ingredient in eight branded drugs marketed by Epic Pharma Llc, 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 fifteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for pilocarpine.

Summary for pilocarpine

US Patents:	6
Tradenames:	8
Applicants:	14
NDAs:	15
Drug Master File Entries:	12
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	50
Patent Applications:	6,838
Drug Prices:	Drug price trends for pilocarpine
DailyMed Link:	pilocarpine at DailyMed

See drug prices for pilocarpine

Recent Clinical Trials for pilocarpine

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 clinical trials

Medical Subject Heading (MeSH) Categories for pilocarpine

Miotics
Muscarinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for pilocarpine

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

US Patents and Regulatory Information for pilocarpine

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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
Rising	PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	204398-002	Sep 27, 2017	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Concordia	SALAGEN	pilocarpine hydrochloride	TABLET;ORAL	020237-001	Mar 22, 1994	AB	RX	Yes	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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