PILOCARPINE HYDROCHLORIDE Drug Patent Profile
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When do Pilocarpine Hydrochloride patents expire, and what generic alternatives are available?
Pilocarpine Hydrochloride is a drug marketed by Amneal, Rising, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us. and is included in eight NDAs.
The generic ingredient in PILOCARPINE HYDROCHLORIDE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pilocarpine Hydrochloride
A generic version of PILOCARPINE HYDROCHLORIDE was approved as pilocarpine hydrochloride by PADAGIS US on November 16th, 2004.
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Questions you can ask:
- What is the 5 year forecast for PILOCARPINE HYDROCHLORIDE?
- What are the global sales for PILOCARPINE HYDROCHLORIDE?
- What is Average Wholesale Price for PILOCARPINE HYDROCHLORIDE?
Summary for PILOCARPINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 50 |
| Patent Applications: | 3,807 |
| What excipients (inactive ingredients) are in PILOCARPINE HYDROCHLORIDE? | PILOCARPINE HYDROCHLORIDE excipients list |
| DailyMed Link: | PILOCARPINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PILOCARPINE HYDROCHLORIDE
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 |
Pharmacology for PILOCARPINE HYDROCHLORIDE
| Drug Class | Cholinergic Receptor Agonist |
| Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for PILOCARPINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PILOCARPINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VUITY | Ophthalmic Solution | pilocarpine hydrochloride | 1.25% | 214028 | 1 | 2022-12-30 |
US Patents and Regulatory Information for PILOCARPINE HYDROCHLORIDE
| 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;OPHTHALMIC | 214193-001 | Sep 21, 2020 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Us | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | TABLET;ORAL | 076746-001 | Nov 16, 2004 | AB | RX | No | No | ⤷ 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
