Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
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Mallinckrodt
Moodys
Express Scripts

Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Levocetirizine dihydrochloride - Generic Drug Details

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What are the generic drug 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 Inc, L Perrigo Co, Lannett Co Inc, Taro Pharm Inds Ltd, Hetero Labs Ltd Iii, Sanofi Aventis Us, Dr Reddys Labs Ltd, Fosun Pharma, Glenmark Generics, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Neopharma, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms, and is included in twenty-five 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. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for levocetirizine dihydrochloride

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Drug Sales Revenue Trends for levocetirizine dihydrochloride

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Recent Clinical Trials for levocetirizine dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 4
University Hospital, GrenoblePhase 4
Zensei Pharmaceutical Co., Ltd.Phase 1

See all levocetirizine dihydrochloride clinical trials

Recent Litigation for levocetirizine dihydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Sunovion Pharmaceuticals Inc. v. Barr Laboratories, Inc.2008-07-30
Sepracor Inc. v. Synthon Pharmaceuticals, Inc.2008-04-10

See all levocetirizine dihydrochloride litigation

PTAB Litigation
PetitionerDate
Apotex Inc.2018-12-13

See all levocetirizine dihydrochloride litigation

Generic filers with tentative approvals for LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MG/5MLSOLUTION;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
Synonyms for levocetirizine dihydrochloride
(-)-Cetirizine 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)-2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid dihydrochloride
(R)-Cetirizine diHCl (Levocetirizine diHCl)
(R)-Cetirizine dihydrochloride
[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]acetic acid dihydrochloride
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
BCP21544
BG0136
CHEMBL1201190
CTK8F2040
D08118
FT-0631130
KS-00000XIF
KS-1177
L0264
Levoceitrizine dihydrochloride
Levocetirizine 2HCl
Levocetirizine diHCl
Levocetirizine dihydrochloride (USAN)
Levocetirizine dihydrochloride [USAN]
Levocetirizine dihydrochloride, >=98% (HPLC)
Levocetirizine HCl
Levocetirizine hydrochloride (JAN)
Levocetirizine Hydrochloride,(S)
Levocetirizine pound>>(R)-Cetirizine (hydrochloride)
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
Xyzal (TN)
Xyzal Allergy 24hr
Xyzall
Paragraph IV (Patent) Challenges for LEVOCETIRIZINE DIHYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
XYZAL ALLERGY 24HR SOLUTION;ORAL levocetirizine dihydrochloride 209090 2018-01-04
XYZAL SOLUTION;ORAL levocetirizine dihydrochloride 022157 2009-01-14
XYZAL TABLET;ORAL levocetirizine dihydrochloride 022064 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
Sun Pharm Inds Ltd LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 201653-001 Jun 26, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Generics LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090385-001 Feb 24, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Taro Pharm Inds Ltd LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 202673-001 Jul 26, 2013 AA RX No No   Start Trial   Start Trial   Start Trial
Perrigo R And D LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 211983-001 Mar 28, 2019 OTC No No   Start Trial   Start Trial   Start Trial
>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
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157-001 Jan 28, 2008   Start Trial   Start Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007   Start Trial   Start Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for levocetirizine dihydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663828 C300085 Netherlands   Start 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
0058146 2001C/045 Belgium   Start Trial 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Dow
Moodys
McKesson
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.