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RECLAST Drug Profile
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See Plans and PricingWhen do Reclast patents expire, and what generic 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.
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.
US ANDA 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: | 100 |
| Clinical Trials: | 10 |
| Patent Applications: | 2,772 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RECLAST |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RECLAST |
| DailyMed Link: | RECLAST at DailyMed |
Recent Clinical Trials for RECLAST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Parkinson's Foundation | Phase 4 |
| California Pacific Medical Center Research Institute | Phase 4 |
| Duke University | Phase 4 |
Recent Litigation for RECLAST
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NOVARTIS PHARMACEUTICALS CORPORATION v. PAR STERILE PRODUCTS, LLC | 2014-12-03 |
| NOVARTIS PHARMACEUTICALS CORPORATION v. AKORN, INC. | 2013-11-08 |
| NOVARTIS PHARMACEUTICALS CORPORATION v. AKORN, INC. | 2013-08-26 |
Pharmacology for RECLAST
| Drug Class | Bisphosphonate |
Synonyms for RECLAST
| (1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl)bis(phosphonic acid) |
| (1-Hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl)diphosphonic acid |
| (1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bisphosphonic acid |
| (1-hydroxy-2-imidazol-1-yl-1-phosphono-ethyl)phosphonic acid |
| (1-hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid |
| (1-Hydroxy-2-imidazol-1-ylethylidene)diphosphonic acid |
| [1-hydroxy-(1H-imidazol-1-yl)-phosphonoethyl] phos |
| [1-hydroxy-2-(1H-imidazol-1-yl)-1-phosphonoethyl]phosphonic acid |
| [1-HYDROXY-2-(1H-IMIDAZOL-1-YL)-ETHYLIDENE]BISPHOSPHONIC ACID |
| [1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl]bis(phosphonic acid) |
| [1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic acid |
| 072Z938 |
| 1-Hydroxy-2-(1-imidazolyl)ethane-1,1-diphosphonic Acid |
| 1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyldiphosphonic acid |
| 118072-93-8 |
| 2-(imidazol-1-yl)-1-hydroxyethane-1,1-diphosphonic acid |
| 42181-EP2270008A1 |
| 42181-EP2292617A1 |
| 42181-EP2295426A1 |
| 42181-EP2295427A1 |
| 42181-EP2308855A1 |
| 42181-EP2311808A1 |
| 42181-EP2311829A1 |
| 4CH-021386 |
| 70HZ18PH24 |
| AB0013187 |
| AB01273947_04 |
| AB01273947-01 |
| AB01273947-02 |
| AB01273947-03 |
| AB07564 |
| AC-1092 |
| AC1L2ACJ |
| AC1Q6RN3 |
| Aclasta |
| Aclasta and Reclast |
| AK-81486 |
| AKOS005145739 |
| AN-5259 |
| Anhydrous Zoledronic Acid |
| ANW-57498 |
| API0004654 |
| BC206233 |
| BCP22750 |
| BDBM12578 |
| BIDD:GT0292 |
| BIDD:PXR0134 |
| Bisphosphonate 3 |
| BPH 91 |
| C-17113 |
| C5H10N2O7P2 |
| CAS-118072-93-8 |
| CGP 42446 |
| CGP-42446 |
| CGP-42446A |
| CHEBI:46557 |
| CHEMBL924 |
| CS-1829 |
| CTK8A6898 |
| D08689 |
| DB00399 |
| DSSTox_CID_22668 |
| DSSTox_GSID_42668 |
| DSSTox_RID_80065 |
| DTXSID0042668 |
| EBD33252 |
| FT-0082657 |
| FT-0601384 |
| GP9100 |
| GTPL3177 |
| HMS2089O09 |
| HS-0091 |
| HY-13777 |
| I06-0710 |
| JMC515594 Compound 55 |
| KB-62427 |
| KS-00000NZ4 |
| LS-181815 |
| MCULE-1604726355 |
| MolPort-002-885-874 |
| NCGC00159521-02 |
| NCGC00159521-03 |
| NCGC00159521-04 |
| NCGC00159521-05 |
| NSC-721517 |
| NSC721517 |
| Orazol |
| PHO012 |
| Phosphonic acid, (1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bis- |
| Phosphonic acid, [1-hydroxy-2-(1H-imidazol-1-yl)ethylidene]bis- |
| PubChem14894 |
| Q-201946 |
| Reclast (TN) |
| RP06507 |
| RTA-01011 |
| S00092 |
| s1314 |
| SC-14082 |
| SCHEMBL19054 |
| SR-05000001436 |
| SR-05000001436-1 |
| ST24033505 |
| STL452893 |
| Tox21_111739 |
| UNII-70HZ18PH24 |
| XRASPMIURGNCCH-UHFFFAOYSA-N |
| Y1607 |
| Z-1463 |
| Z1691545083 |
| ZINC3803652 |
| ZOL |
| ZOL 446 |
| Zoledronate |
| Zoledronic acid |
| Zoledronic acid (INN) |
| Zoledronic Acid (Zoledronate) |
| Zoledronic acid [USAN:INN:BAN] |
| Zoledronic acid [USAN:INN] |
| Zoledronic Acid Anhydrous |
| Zoledronic Acid, Anhydrous |
| Zoledronic acid, Zoledronate |
| Zomera |
| Zometa |
| Zometa (Novartis) |
| Zometa (TN) |
| Zometa Concentrate |
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 |
|---|---|---|
| Japan | 2003535889 | Start Trial |
| Japan | 4802096 | Start Trial |
| Denmark | 1591122 | Start Trial |
| Israel | 153229 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RECLAST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1591122 | 2013C/022 | Belgium | Start Trial | PRODUCT NAME: ACIDE ZOLEDRONIQUE; AUTHORISATION NUMBER AND DATE: C(2007)4619 20071003 |
| 1591122 | 92174 | Luxembourg | Start Trial | PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI |
| 1591122 | 122013000031 | Germany | Start Trial | 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 |
| 0275821 | SPC/GB01/039 | United Kingdom | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
