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 |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | Phase 3 |
| Maastricht University Medical Center | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Concordia | SALAGEN | pilocarpine hydrochloride | TABLET;ORAL | 020237-002 | Apr 18, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Somerset Theraps Llc | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 210384-001 | Nov 25, 2019 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | ISOPTO CARPINE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 200890-002 | Jun 22, 2010 | AT | RX | Yes | Yes | ⤷ 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 |
