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RECLAST Drug Profile
» See Plans and Pricing
Which patents cover Reclast, and when can generic versions of Reclast launch?
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.
This drug has sixty-nine patent family members in thirty-six countries.
The generic ingredient in RECLAST is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Reclast
A generic version of RECLAST was approved as zoledronic acid by BRECKENRIDGE on March 4th, 2013.
Summary for RECLAST
| International Patents: | 69 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 106 |
| Clinical Trials: | 12 |
| Patent Applications: | 3,758 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RECLAST |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RECLAST |
| What excipients (inactive ingredients) are in RECLAST? | RECLAST excipients list |
| DailyMed Link: | RECLAST at DailyMed |
Recent Clinical Trials for RECLAST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Australian and New Zealand Intensive Care Research Centre | Phase 2 |
| University of Nebraska | Phase 1/Phase 2 |
| Parkinson's Foundation | Phase 4 |
Pharmacology for RECLAST
| Drug Class | Bisphosphonate |
Paragraph IV (Patent) Challenges for RECLAST
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RECLAST | INJECTABLE;INTRAVENOUS | zoledronic acid | 021817 | 2008-08-29 |
US Patents and Regulatory Information for RECLAST
| 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;INTRAVENOUS | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Novartis | RECLAST | zoledronic acid | INJECTABLE;INTRAVENOUS | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 RECLAST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | RECLAST | zoledronic acid | INJECTABLE;INTRAVENOUS | 021817-001 | Apr 16, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RECLAST
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 3776880 | Start Trial |
| New Zealand | 222610 | Start Trial |
| South Africa | 200210361 | Start Trial |
| Peru | 20050468 | Start Trial |
| Portugal | 86167 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RECLAST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1591122 | C300582 | Netherlands | Start Trial | PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003 |
| 0258618 | SPC/GB01/042 | United Kingdom | Start Trial | 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 |
| 1591122 | CA 2013 00016 | Denmark | Start Trial | PRODUCT NAME: ZOLEDRONSYRE ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET VILKARLIGT HYDRAT DERAF; NAT. REG. NO/DATE: EU/1/05/308, C(2007)4619 20071003; FIRST REG. NO/DATE: CH 57363 20070927 |
| 1591122 | 92174 | Luxembourg | Start Trial | PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI |
| 1591122 | C01591122/01 | Switzerland | Start Trial | PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
