LEVOCETIRIZINE DIHYDROCHLORIDE Drug Patent Profile
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When do Levocetirizine Dihydrochloride patents expire, and when can generic versions of Levocetirizine Dihydrochloride launch?
Levocetirizine Dihydrochloride is a drug marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules, Hetero Labs Ltd Iii, Ipca Labs Ltd, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Us Antibiotics. and is included in twenty-three NDAs.
The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE 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 Dihydrochloride
A generic version of LEVOCETIRIZINE DIHYDROCHLORIDE was approved as levocetirizine dihydrochloride by SYNTHON PHARMS on November 26th, 2010.
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Summary for LEVOCETIRIZINE DIHYDROCHLORIDE
See drug prices for LEVOCETIRIZINE DIHYDROCHLORIDE
Recent Clinical Trials for LEVOCETIRIZINE DIHYDROCHLORIDE
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 DIHYDROCHLORIDE
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for LEVOCETIRIZINE DIHYDROCHLORIDE
Paragraph IV (Patent) Challenges for LEVOCETIRIZINE DIHYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| XYZAL | Oral Solution | levocetirizine dihydrochloride | 0.5 mg/mL | 022157 | 1 | 2009-01-14 |
| XYZAL | Tablets | levocetirizine dihydrochloride | 5 mg | 022064 | 1 | 2007-12-17 |
US Patents and Regulatory Information for LEVOCETIRIZINE DIHYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 202915-001 | Aug 21, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sciegen Pharms Inc | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 203646-001 | Sep 9, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 210375-001 | Jan 19, 2018 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Taro | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 202673-001 | Jul 26, 2013 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd Iii | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 213513-001 | Apr 29, 2020 | OTC | 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 |
