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Generated: September 21, 2017
What is the patent landscape for Reclast, and what generic Reclast alternatives are available?
Reclast is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 86 |
| Clinical Trials: see list | 8 |
| Patent Applications: see list | 2,770 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | RECLAST at DailyMed |
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | RECLAST | zoledronic acid | INJECTABLE;IV (INFUSION) | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Novartis | RECLAST | zoledronic acid | INJECTABLE;IV (INFUSION) | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| zoledronic acid | Injection | 0.05 mg/mL, 100 mL vial | Reclast | 8/29/2008 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | 0111806 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20061682 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 100864743 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 20024134 | ► Subscribe | |||||||||||||||||||||||||||
| Colombia | 5680461 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1591122 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2247123 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5005188 | ► Subscribe | |||||||||||||||||||||||||||
| Tunisia | SN06084 | ► Subscribe | |||||||||||||||||||||||||||
| Morocco | 28078 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013 00016 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 2013000031 | Germany | ► Subscribe | PRODUCT NAME: ZOLEDRONSAEURE ODER PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER BELIEBIGES HYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/05/308/001-002 20071003; FIRST REGISTRATION: SCHWEIZ 57363 20070927 | ||||||||||||||||||||||||||
| C/GB01/039 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 00582 | Netherlands | ► Subscribe | PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003 | ||||||||||||||||||||||||||
| 0582 | Netherlands | ► Subscribe | PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003 | ||||||||||||||||||||||||||
| 174 | Luxembourg | ► Subscribe | PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI | ||||||||||||||||||||||||||
| C/GB01/042 | United Kingdom | ► Subscribe | PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320 | ||||||||||||||||||||||||||
| C0035 | France | ► Subscribe | PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128 | ||||||||||||||||||||||||||
| 1591122/01 | Switzerland | ► Subscribe | PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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