ZEMPLAR Drug Patent Profile
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When do Zemplar patents expire, 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.
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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: | 1,758 |
| 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 D Analog Vitamin D2 Analog |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-002 | Feb 1, 2000 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-002 | May 26, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-003 | May 26, 2005 | DISCN | Yes | No | ⤷ 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 ZEMPLAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-002 | Feb 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-003 | Feb 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ZEMPLAR | paricalcitol | SOLUTION;INTRAVENOUS | 020819-001 | Apr 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-002 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 9702826 | ⤷ Sign Up | |
| Japan | H0667899 | ⤷ Sign Up | |
| Japan | 2011037860 | COSOLVENT FORMULATION | ⤷ Sign Up |
| Canada | 2326198 | FORMULATIONS DE COSOLVANTS (COSOLVENT FORMULATIONS) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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 |
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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.
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