Levocetirizine dihydrochloride - Generic Drug Details
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What are the generic sources for levocetirizine dihydrochloride and what is the scope of freedom to operate?
Levocetirizine dihydrochloride
is the generic ingredient in four branded drugs marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Hetero Labs Ltd Iii, Chattem Sanofi, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules, 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-eight NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Levocetirizine dihydrochloride has thirty patent family members in twenty-four countries.
There are eleven drug master file entries for levocetirizine dihydrochloride. Fifty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for levocetirizine dihydrochloride
International Patents: | 30 |
US Patents: | 1 |
Tradenames: | 4 |
Applicants: | 21 |
NDAs: | 28 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 50 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Clinical Trials: | 67 |
Patent Applications: | 272 |
Drug Prices: | Drug price trends for levocetirizine dihydrochloride |
Drug Sales Revenues: | Drug sales revenues for levocetirizine dihydrochloride |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for levocetirizine dihydrochloride |
What excipients (inactive ingredients) are in levocetirizine dihydrochloride? | levocetirizine dihydrochloride excipients list |
DailyMed Link: | levocetirizine dihydrochloride at DailyMed |
Recent Clinical Trials for levocetirizine dihydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eurofarma Laboratorios S.A. | Phase 3 |
Mostafa Bahaa | Phase 2 |
Maryam Ali Ali El Sayed Rizk Clinical pharmacy Department- Tanta University | Phase 2 |
Generic filers with tentative approvals for LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 2.5MG/5ML | SOLUTION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd Iii | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 091264-001 | Jun 29, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ipca Labs Ltd | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 204626-001 | May 6, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm Inds Ltd | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 201653-001 | Jun 26, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apotex | LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 211443-001 | Apr 21, 2021 | 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 |
Expired US Patents for levocetirizine dihydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chattem Sanofi | XYZAL | levocetirizine dihydrochloride | SOLUTION;ORAL | 022157-001 | Jan 28, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Chattem Sanofi | XYZAL | levocetirizine dihydrochloride | TABLET;ORAL | 022064-001 | May 25, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Chattem Sanofi | XYZAL | levocetirizine dihydrochloride | TABLET;ORAL | 022064-001 | May 25, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for levocetirizine dihydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 200700067 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2006005507 | ⤷ Sign Up | |
Mexico | 2007000230 | PREPARACIONES FARMACEUTICAS DE DERIVADOS DE PIPERAZINA. (PHARMACEUTICAL COMPOSITION OF PIPERAZINE DERIVATIVES.) | ⤷ Sign Up |
China | 100508981 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for levocetirizine dihydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0663828 | C300085 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103 |
0058146 | 2001C/045 | Belgium | ⤷ Sign Up | PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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