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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Questions you can ask:
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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 |
---|---|---|---|
Israel | 159287 | ⤷ Sign Up | |
Netherlands | 300074 | ⤷ Sign Up | |
El Salvador | 1997000026 | COMPOSICIONES FARMACEUTICAS PARA EL TRATAMIENTO DE LA RINITIS | ⤷ Sign Up |
Australia | 1774097 | ⤷ Sign Up | |
Romania | 122476 | TABLETĂ CONŢINÂND CETIRIZINĂ ŞI PSEUDOEFEDRINĂ (TABLET CONTAINING CETIRIZINE AND PSEUDOEPHEDRINE) | ⤷ Sign Up |
Portugal | 74390 | NOUVEAUX ACIDES 2-<4-(DIPHENYLMETHYL)-1-PIPERAZINYL>-ACETIQUES ET LEURS AMIDES LEURS PROCEDES DE PREPARATION ET COMPOSITIONS THERAPEUTIQUES | ⤷ Sign Up |
South Korea | 20040007756 | ⤷ 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 |
---|---|---|---|---|
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 |
0058146 | SPC/GB01/052 | United Kingdom | ⤷ Sign Up | SPC/GB01/052:, EXPIRES: 20070205 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |