LEVOCETIRIZINE HYDROCHLORIDE Drug Patent Profile
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When do Levocetirizine Hydrochloride patents expire, and what generic alternatives are available?
Levocetirizine Hydrochloride is a drug marketed by Hetero Labs Ltd Iii and is included in one NDA.
The generic ingredient in LEVOCETIRIZINE HYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levocetirizine Hydrochloride
A generic version of LEVOCETIRIZINE HYDROCHLORIDE was approved as levocetirizine dihydrochloride by SYNTHON PHARMS on November 26th, 2010.
Summary for LEVOCETIRIZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 67 |
| Patent Applications: | 20 |
| DailyMed Link: | LEVOCETIRIZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for LEVOCETIRIZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eurofarma Laboratorios S.A. | Phase 3 |
| Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta University | Phase 2 |
| Mostafa Bahaa | Phase 2 |
Pharmacology for LEVOCETIRIZINE HYDROCHLORIDE
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for LEVOCETIRIZINE HYDROCHLORIDE
US Patents and Regulatory Information for LEVOCETIRIZINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hetero Labs Ltd Iii | LEVOCETIRIZINE HYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 210914-001 | Apr 1, 2019 | AA | RX | 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 |
