Cetirizine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details
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What are the generic sources for cetirizine hydrochloride; pseudoephedrine hydrochloride and what is the scope of freedom to operate?
Cetirizine hydrochloride; pseudoephedrine hydrochloride
is the generic ingredient in two branded drugs marketed by Ivax Sub Teva Pharms, Perrigo R And D, Pld Acquisitions, Sun Pharm Inds Ltd, and J And J Consumer Inc, and is included in five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cetirizine hydrochloride; pseudoephedrine hydrochloride has forty-six patent family members in thirty-five countries.
Twenty-four suppliers are listed for this compound.
Summary for cetirizine hydrochloride; pseudoephedrine hydrochloride
International Patents: | 46 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 24 |
Clinical Trials: | 4 |
DailyMed Link: | cetirizine hydrochloride; pseudoephedrine hydrochloride at DailyMed |
Recent Clinical Trials for cetirizine hydrochloride; pseudoephedrine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GlaxoSmithKline | N/A |
Fraunhofer-Institute of Toxicology and Experimental Medicine | N/A |
Sandoz | Phase 1 |
See all cetirizine hydrochloride; pseudoephedrine hydrochloride clinical trials
Pharmacology for cetirizine hydrochloride; pseudoephedrine hydrochloride
Drug Class | Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for cetirizine hydrochloride; pseudoephedrine hydrochloride
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZYRTEC-D 12 HOUR | Extended-release Tablets | cetirizine hydrochloride; pseudoephedrine hydrochloride | 5 mg/120 mg | 021150 | 1 | 2004-06-02 |
US Patents and Regulatory Information for cetirizine hydrochloride; pseudoephedrine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ivax Sub Teva Pharms | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077170-001 | Feb 25, 2008 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Sun Pharm Inds Ltd | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090922-001 | Sep 28, 2012 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Perrigo R And D | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210719-001 | Nov 16, 2018 | 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 cetirizine hydrochloride; pseudoephedrine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for cetirizine hydrochloride; pseudoephedrine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Czech Republic | 20033454 | ⤷ Sign Up | |
South Korea | 20040007756 | ⤷ Sign Up | |
European Patent Office | 1404304 | COMPRIME CONTENANT DE LA CETIRIZINE ET DE LA PSEUDOEPHEDRINE (TABLET COMPRISING CETIRIZINE AND PSEUDOEPHEDRINE) | ⤷ Sign Up |
Hungary | 229803 | Tablet comprising cetirizine and pseudoephedrine | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cetirizine hydrochloride; pseudoephedrine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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