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CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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.
There are thirty-nine drug master file entries for cetirizine hydrochloride; pseudoephedrine hydrochloride. Twenty-six suppliers are listed for this compound.
Summary for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
| International Patents: | 46 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 5 |
| Drug Master File Entries: | 39 |
| Suppliers / Packagers: | 26 |
| 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 |
|---|---|
| Fraunhofer-Institute of Toxicology and Experimental Medicine | N/A |
| GlaxoSmithKline | N/A |
| Sandoz | Phase 1 |
See all CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZYRTEC-D 12 HOUR | TABLET, EXTENDED RELEASE;ORAL | cetirizine hydrochloride; pseudoephedrine hydrochloride | 021150 | 2004-06-02 |
US Patents and Regulatory Information for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
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 | Start Trial | Start Trial |
| J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Colombia | 5540370 | Start Trial |
| Estonia | 200400005 | Start Trial |
| South Korea | 20040007756 | Start Trial |
| Croatia | P20031057 | Start Trial |
| Hungary | 229803 | Start Trial |
| Malaysia | 129643 | Start Trial |
| Mexico | PA03010430 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
| 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 |
