Pilocarpine hydrochloride - Generic Drug Details
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What are the generic sources for pilocarpine hydrochloride and what is the scope of freedom to operate?
Pilocarpine hydrochloride
is the generic ingredient in six branded drugs marketed by 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 thirteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pilocarpine hydrochloride has fifty-six patent family members in twenty-four countries.
There are seven drug master file entries for pilocarpine hydrochloride. Fifteen suppliers are listed for this compound.
Summary for pilocarpine hydrochloride
| International Patents: | 56 |
| US Patents: | 6 |
| Tradenames: | 6 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Master File Entries: | 7 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 50 |
| Patent Applications: | 6,184 |
| 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 |
|---|---|
| Maastricht University Medical Center | Phase 3 |
| ZonMw: The Netherlands Organisation for Health Research and Development | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Somerset Theraps Llc | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 210384-003 | Nov 25, 2019 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Orasis Pharms | QLOSI | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 217836-001 | Oct 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
| Abbvie | VUITY | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 214028-001 | Oct 28, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 204398-001 | Sep 27, 2017 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alcon | PILOPINE HS | pilocarpine hydrochloride | GEL;OPHTHALMIC | 018796-001 | Oct 1, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | VUITY | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 214028-001 | Oct 28, 2021 | RX | Yes | Yes | ⤷ 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 |
International Patents for pilocarpine hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2023003124 | ⤷ Sign Up | |
| South Korea | 20190051973 | ⤷ Sign Up | |
| Denmark | 3681500 | ⤷ Sign Up | |
| Japan | 7297308 | ⤷ Sign Up | |
| Japan | 6946575 | ⤷ Sign Up | |
| China | 112272558 | 盐酸毛果芸香碱用于治疗眼部病症的用途 (PRESBYOPIA TREATMENTS) | ⤷ Sign Up |
| Israel | 264664 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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