ZEMPLAR Drug Patent Profile
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Which patents cover Zemplar, and what generic alternatives are available?
Zemplar is a drug marketed by Abbvie and is included in two NDAs.
The generic ingredient in ZEMPLAR is paricalcitol. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zemplar
A generic version of ZEMPLAR was approved as paricalcitol by SANDOZ on July 27th, 2011.
Summary for ZEMPLAR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 63 |
Patent Applications: | 1,898 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ZEMPLAR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZEMPLAR |
What excipients (inactive ingredients) are in ZEMPLAR? | ZEMPLAR excipients list |
DailyMed Link: | ZEMPLAR at DailyMed |
Recent Clinical Trials for ZEMPLAR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Emory University | Phase 2 |
Washington University School of Medicine | Phase 1 |
Ipsen | Phase 1 |
Pharmacology for ZEMPLAR
Drug Class | Vitamin D2 Analog |
Anatomical Therapeutic Chemical (ATC) Classes for ZEMPLAR
Paragraph IV (Patent) Challenges for ZEMPLAR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZEMPLAR | Injection | paricalcitol | 0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials | 020819 | 1 | 2008-11-28 |
ZEMPLAR | Capsules | paricalcitol | 1 mcg and 2 mcg | 021606 | 1 | 2008-10-14 |
ZEMPLAR | Capsules | paricalcitol | 4 mcg | 021606 | 1 | 2008-08-25 |
US Patents and Regulatory Information for ZEMPLAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-001 | May 26, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-002 | Feb 1, 2000 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-002 | May 26, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-003 | May 26, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-003 | Feb 1, 2000 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 ZEMPLAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-001 | May 26, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-002 | May 26, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-002 | May 26, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-001 | May 26, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-002 | Feb 1, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZEMPLAR
See the table below for patents covering ZEMPLAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1033857 | ⤷ Try a Trial | |
Netherlands | 300228 | ⤷ Try a Trial | |
Japan | 4664499 | ⤷ Try a Trial | |
Canada | 2224284 | UTILISATION DE COMPOSES DE LA VITAMINE D-19-NOR DANS LA PREVENTION DE L'HYPERPHOSPHATEMIE CHEZ LES PATIENTS SOUFFRANT DE TROUBLES RENAUX (USE OF 19-NOR-VITAMIN D COMPOUNDS FOR THE PREVENTION OF HYPERPHOSPHATEMIA IN KIDNEY DISORDER PATIENTS) | ⤷ Try a Trial |
South Africa | 9007119 | ⤷ Try a Trial | |
Japan | 2016053046 | 共溶媒処方物 (COSOLVENT FORMULATION) | ⤷ Try a Trial |
Hungary | 215604 | Eljárás biológiailag hatásos 19-nor-D-vitamin-vegyületek és ilyen vegyületeket tartalmazó gyógyászati készítmények előállítására (PROCESS FOR PRODUCING BIOLOGICALLY EFFECTIVE 19-NOR-D VITAMIN COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS COMPRISING SUCH COMPOUNDS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEMPLAR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0387077 | SPC/GB04/003 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PARICALCITOL; REGISTERED: ES SPAIN 64.974 20020809; UK PL 00037/0403 20030721 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |