ZYRTEC-D 12 HOUR Drug Patent Profile
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When do Zyrtec-d 12 Hour patents expire, and when can generic versions of Zyrtec-d 12 Hour launch?
Zyrtec-d 12 Hour is a drug marketed by J And J Consumer Inc and is included in one NDA.
The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zyrtec-d 12 Hour
A generic version of ZYRTEC-D 12 HOUR was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25th, 2008.
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Summary for ZYRTEC-D 12 HOUR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 30 |
| Patent Applications: | 1 |
| DailyMed Link: | ZYRTEC-D 12 HOUR at DailyMed |
Recent Clinical Trials for ZYRTEC-D 12 HOUR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emory University | Phase 4 |
| Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Phase 1 |
| Indiana University | Phase 4 |
Pharmacology for ZYRTEC-D 12 HOUR
| Drug Class | Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Paragraph IV (Patent) Challenges for ZYRTEC-D 12 HOUR
| 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 ZYRTEC-D 12 HOUR
| 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-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | OTC | Yes | Yes | ⤷ 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 ZYRTEC-D 12 HOUR
| 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 ZYRTEC-D 12 HOUR
See the table below for patents covering ZYRTEC-D 12 HOUR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 8406455 | ⤷ Sign Up | |
| Russian Federation | 2004101231 | ⤷ Sign Up | |
| United Kingdom | 9706842 | ⤷ Sign Up | |
| Denmark | 1404304 | ⤷ Sign Up | |
| Bosnia and Herzegovina | 97199 | ⤷ Sign Up | |
| Yugoslavia | 43511 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZYRTEC-D 12 HOUR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0058146 | SPC/GB01/052 | United Kingdom | ⤷ Sign Up | SPC/GB01/052:, EXPIRES: 20070205 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
ISSN: 2162-2639
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