Pilocarpine - Generic Drug Details
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, Fdc Ltd, Rising, Somerset Theraps Llc, Orasis Pharms, Abbvie, Impax Labs, Innogenix, Lannett Co Inc, Padagis Us, Quagen, and Advanz Pharma, and is included in seventeen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Summary for pilocarpine
| US Patents: | 6 |
| Tradenames: | 8 |
| Applicants: | 15 |
| NDAs: | 17 |
| Drug Master File Entries: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 57 |
| Drug Prices: | Drug price trends 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | VUITY | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 214028-001 | Oct 28, 2021 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Orasis Pharms | QLOSI | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 217836-001 | Oct 17, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amneal | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 214193-001 | Sep 21, 2020 | AT | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Somerset Theraps Llc | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 210384-001 | Nov 25, 2019 | AT | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Orasis Pharms | QLOSI | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 217836-001 | Oct 17, 2023 | RX | Yes | Yes | ⤷ 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 |
