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ZYRTEC HIVES RELIEF Drug Profile
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When do Zyrtec Hives Relief patents expire, and what generic alternatives are available?
Zyrtec Hives Relief is a drug marketed by J And J Consumer Inc and is included in one NDA.
The generic ingredient in ZYRTEC HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and thirty-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Zyrtec Hives Relief
A generic version of ZYRTEC HIVES RELIEF was approved as cetirizine hydrochloride by TEVA PHARMS on May 27th, 2008.
Summary for ZYRTEC HIVES RELIEF
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 104 |
| Clinical Trials: | 29 |
| Patent Applications: | 1,891 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ZYRTEC HIVES RELIEF at DailyMed |
Recent Clinical Trials for ZYRTEC HIVES RELIEF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Phase 1 |
| Indiana University | Phase 4 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Early Phase 1 |
US Patents and Regulatory Information for ZYRTEC HIVES RELIEF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET;ORAL | 019835-005 | Nov 16, 2007 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| J And J Consumer Inc | ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET;ORAL | 019835-006 | Nov 16, 2007 | DISCN | Yes | 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 |
International Patents for ZYRTEC HIVES RELIEF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 134903 | Start Trial |
| Bosnia and Herzegovina | 97198 | Start Trial |
| Finland | 820318 | Start Trial |
| Denmark | 154078 | Start Trial |
| Denmark | 5388 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZYRTEC HIVES RELIEF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0058146 | SPC/GB01/052 | United Kingdom | Start Trial | SPC/GB01/052:, EXPIRES: 20070205 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
