PILOCARPINE Drug Patent Profile
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When do Pilocarpine patents expire, and when can generic versions of Pilocarpine launch?
Pilocarpine is a drug marketed by Amneal, Fdc Ltd, Rising, Somerset Theraps Llc, Aurobindo Pharma Usa, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us. and is included in ten NDAs.
The generic ingredient in PILOCARPINE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pilocarpine
A generic version of PILOCARPINE was approved as pilocarpine hydrochloride by INNOGENIX on December 22nd, 2004.
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Questions you can ask:
- What is the 5 year forecast for PILOCARPINE?
- What are the global sales for PILOCARPINE?
- What is Average Wholesale Price for PILOCARPINE?
Summary for PILOCARPINE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 10 |
| Drug Prices: | Drug price information for PILOCARPINE |
| DailyMed Link: | PILOCARPINE at DailyMed |
Recent Clinical Trials for PILOCARPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Southern College of Optometry | PHASE4 |
| Mansoura University | NA |
| Novus Vision LLC | EARLY_PHASE1 |
Medical Subject Heading (MeSH) Categories for PILOCARPINE
Anatomical Therapeutic Chemical (ATC) Classes for PILOCARPINE
US Patents and Regulatory Information for PILOCARPINE
| 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/DROPS;OPHTHALMIC | 214193-001 | Sep 21, 2020 | AT | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Innogenix | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | TABLET;ORAL | 076963-001 | Dec 22, 2004 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Fdc Ltd | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 217052-003 | Oct 2, 2025 | AT | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
