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CHILDREN'S ZYRTEC ALLERGY Drug Profile
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Which patents cover Children's Zyrtec Allergy, and what generic alternatives are available?
Children's Zyrtec Allergy is a drug marketed by J And J Consumer Inc and is included in two NDAs.
The generic ingredient in CHILDREN'S ZYRTEC ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Children's Zyrtec Allergy
A generic version of CHILDREN'S ZYRTEC ALLERGY was approved as cetirizine hydrochloride by TEVA PHARMS on May 27th, 2008.
Summary for CHILDREN'S ZYRTEC ALLERGY
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,891 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | CHILDREN'S ZYRTEC ALLERGY at DailyMed |
Recent Clinical Trials for CHILDREN'S ZYRTEC ALLERGY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 4 |
| Merck Sharp & Dohme Corp. | Phase 3 |
| Johnson & Johnson Consumer and Personal Products Worldwide | Phase 4 |
Paragraph IV (Patent) Challenges for CHILDREN'S ZYRTEC ALLERGY
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CHILDREN'S ZYRTEC HIVES RELIEF | TABLET, CHEWABLE;ORAL | cetirizine hydrochloride | 021621 | 2005-03-25 |
| CHILDREN'S ZYRTEC ALLERGY | TABLET, CHEWABLE;ORAL | cetirizine hydrochloride | 021621 | 2005-03-25 |
US Patents and Regulatory Information for CHILDREN'S ZYRTEC ALLERGY
| 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 | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | SYRUP;ORAL | 022155-002 | Nov 16, 2007 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-003 | Nov 16, 2007 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-004 | 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 |
Expired US Patents for CHILDREN'S ZYRTEC ALLERGY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-003 | Nov 16, 2007 | Start Trial | Start Trial |
| J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-004 | Nov 16, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CHILDREN'S ZYRTEC ALLERGY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Malaysia | 8700279 | Start Trial |
| Japan | S6311353 | Start Trial |
| Poland | 134903 | Start Trial |
| Finland | 75816 | Start Trial |
| South Korea | 20010014398 | Start Trial |
| China | 1261799 | Start Trial |
| New Zealand | 501820 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CHILDREN'S ZYRTEC ALLERGY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
