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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pilocarpine hydrochloride has fifty-three patent family members in twenty-four countries.
There are seven drug master file entries for pilocarpine hydrochloride. Fourteen suppliers are listed for this compound.
Summary for pilocarpine hydrochloride
International Patents: | 53 |
US Patents: | 5 |
Tradenames: | 6 |
Applicants: | 13 |
NDAs: | 13 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 50 |
Patent Applications: | 5,881 |
Formulation / Manufacturing: | see details |
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 |
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
International Patents for pilocarpine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3681500 | ⤷ Try a Trial | |
Slovenia | 3681500 | ⤷ Try a Trial | |
Hungary | E058931 | ⤷ Try a Trial | |
Mexico | 2020011301 | USO DE CLORHIDRATO DE PILOCARPINA PARA EL TRATAMIENTO DE AFECCIONES OCULARES. (USE OF PILOCARPINE HYDROCHLORIDE FOR THE TREATMENT OF OCULAR CONDITIONS.) | ⤷ Try a Trial |
China | 112272558 | 盐酸毛果芸香碱用于治疗眼部病症的用途 (PRESBYOPIA TREATMENTS) | ⤷ Try a Trial |
Canada | 3031370 | COMPOSITIONS PHARMACEUTIQUES OPHTALMIQUES ET UTILISATIONS ASSOCIEES (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO) | ⤷ Try a Trial |
Canada | 3162141 | TRAITEMENTS DE LA PRESBYTIE (PRESBYOPIA TREATMENTS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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