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 five 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: | 5 |
| Tradenames: | 8 |
| Applicants: | 14 |
| NDAs: | 15 |
| Drug Master File Entries: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 50 |
| Patent Applications: | 6,838 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Maastricht University Medical Center | Phase 3 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Phase 3 |
| Ocuphire Pharma, Inc. | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | TABLET;ORAL | 077248-001 | Mar 31, 2006 | 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 | ||||
| Rising | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 204398-001 | Sep 27, 2017 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Padagis Us | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | TABLET;ORAL | 076746-001 | Nov 16, 2004 | 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 |
