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RECLAST Drug Profile
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This drug has sixty-three patent family members in thirty-five countries.
The generic ingredient in RECLAST is zoledronic acid. There are twenty-five drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are eleven tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.
Summary for Tradename: RECLAST
| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Drug Prices: : | see details |
Pharmacology for Tradename: RECLAST
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
Clinical Trials for: RECLAST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | RECLAST | zoledronic acid | INJECTABLE;IV (INFUSION) | 021817-001 | Apr 16, 2007 | RX | Yes | 8,052,987 | Oct 27, 2023 | ||||||||||||||||||||
Novartis | RECLAST | zoledronic acid | INJECTABLE;IV (INFUSION) | 021817-001 | Apr 16, 2007 | RX | Yes | 7,932,241*PED | Aug 5, 2028 | Y | |||||||||||||||||||
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Expired Patents for Tradename: RECLAST
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | RECLAST | zoledronic acid | INJECTABLE;IV (INFUSION) | 021817-001 | Apr 16, 2007 | 4,939,130*PED | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: RECLAST
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| zoledronic acid | Injection | 0.05 mg/mL, 100 mL vial | Reclast | 8/29/2008 |
International Patent Family for Tradename: RECLAST
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | 0111806 | <disabled in preview> | |||||||||||||||||||||||||||
| Poland | 203087 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 1591122 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: RECLAST
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1591122/01 | Switzerland | <disabled> | PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007 | ||||||||||||||||||||||||||
| C/GB01/039 | United Kingdom | <disabled> | PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128 | ||||||||||||||||||||||||||
| 2013 00016 | Denmark | <disabled> | |||||||||||||||||||||||||||
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