ALCAFTADINE Drug Patent Profile
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When do Alcaftadine patents expire, and what generic alternatives are available?
Alcaftadine is a drug marketed by Eugia Pharma and Gland Pharma Ltd and is included in two NDAs.
The generic ingredient in ALCAFTADINE is alcaftadine. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alcaftadine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Alcaftadine
A generic version of ALCAFTADINE was approved as alcaftadine by GLAND PHARMA LTD on March 1st, 2024.
Summary for ALCAFTADINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 4 |
| Patent Applications: | 127 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALCAFTADINE |
| DailyMed Link: | ALCAFTADINE at DailyMed |
Recent Clinical Trials for ALCAFTADINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Allergan | |
| Starx Research Center, LLC | Phase 4 |
| Allergan | Phase 4 |
Pharmacology for ALCAFTADINE
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ALCAFTADINE
Paragraph IV (Patent) Challenges for ALCAFTADINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LASTACAFT | Ophthalmic Solution | alcaftadine | 0.25% | 022134 | 1 | 2014-07-30 |
US Patents and Regulatory Information for ALCAFTADINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 210659-001 | Jun 23, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gland Pharma Ltd | ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 209706-001 | Mar 1, 2024 | OTC | 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 |
