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Covington
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Baxter
Fuji
Healthtrust
Harvard Business School
US Army
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Generated: February 18, 2019

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Levocetirizine dihydrochloride - Generic Drug Details

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What are the generic drug sources for levocetirizine dihydrochloride and what is the scope of levocetirizine dihydrochloride freedom to operate?

Levocetirizine dihydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, L Perrigo Co, Lannett Co Inc, Taro Pharm Inds Ltd, Sanofi Aventis Us, Dr Reddys Labs Ltd, Fosun Pharma, Glenmark Generics, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Neopharma, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharma Global, Synthon Pharms, and Teva Pharms, and is included in twenty-three 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 thirteen drug master file entries for levocetirizine dihydrochloride. Thirty-nine suppliers are listed for this compound.

Pharmacology for levocetirizine dihydrochloride
Synonyms for levocetirizine dihydrochloride
(-)-Cetirizine dihydrochloride; 2-[2-[4-[(R)-(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride
(2-(4-((R)-(4-Chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)acetic acid dihydrochloride
(R)-Cetirizine dihydrochloride
[2-[4-[(R)-(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-acetic acid 2HCl
[2-[4-[(R)-(4-CHLOROPHENYL)PHENYLMETHYL]-1-PIPERAZINYL]ETHOXY]-ACETIC ACID DIHYDROCHLORIDE
018L870
130018-87-0
2-[2-[4-[(R)-(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]ethanoic acid dihydrochloride
2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride
2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid;dihydrochloride
2-[2-[4-[(R)-(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride
A806003
AC-549
Acetic acid, (2-(4-((R)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, dihydrochloride
AK176131
AKOS015994681
API0000012
API0003160
AT-15143
BC204366
BG0136
CHEMBL1201190
CTK8F2040
D08118
FT-0631130
KS-00000XIF
KS-1177
L0264
Levoceitrizine dihydrochloride
Levocetirizine 2HCl
Levocetirizine dihydrochloride (USAN)
Levocetirizine dihydrochloride [USAN]
Levocetirizine dihydrochloride, >=98% (HPLC)
Levocetirizine HCl
Levocetirizine hydrochloride (JAN)
LS-186529
MFCD07366507
MolPort-003-983-419
PGLIUCLTXOYQMV-GHVWMZMZSA-N
SCHEMBL144375
SOD6A38AGA
UCB 28556
UCB-28556
UNII-64O047KTOA component PGLIUCLTXOYQMV-GHVWMZMZSA-N
UNII-SOD6A38AGA
Xusal
Xyzal (TN)
Xyzal Allergy 24hr
Xyzall

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
Sciegen Pharms Inc LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 203646-001 Sep 9, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us XYZAL ALLERGY 24HR levocetirizine dihydrochloride TABLET;ORAL 209089-001 Jan 31, 2017 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for levocetirizine dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157-001 Jan 28, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for levocetirizine dihydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01C/045 Belgium ➤ Try a Free Trial PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
00085 Netherlands ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Chinese Patent Office
US Department of Justice
Johnson and Johnson
Julphar
Teva
Baxter
Mallinckrodt

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