DrugPatentWatch Database Preview
RECLAST Drug Profile
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.
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.
Summary for RECLAST
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 91 |
| Clinical Trials: | 9 |
| 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 |
Pharmacology for RECLAST
| Ingredient-type | Diphosphonates |
| 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-phosphono-ethyl)phosphonic acid |
| (1-hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid |
| (1-hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic acid monohydrate |
| (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)-1,1-ETHANEDIYL]BIS(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 |
| 2-(imidazol-1-yl)-1-hydroxyethylidene-1,1-bisphosphonic 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 (TN) |
| Aclasta and Reclast |
| AK-81486 |
| AKOS005145739 |
| AN-5259 |
| Anhydrous Zoledronic Acid |
| ANW-57498 |
| API0004654 |
| BC206233 |
| BDBM12578 |
| BIDD:GT0292 |
| BIDD:PXR0134 |
| Bio-0112 |
| Bisphosphonate 3 |
| BPH 91 |
| C-17113 |
| C5H10N2O7P2 |
| CAS-118072-93-8 |
| CGP 42'446 |
| CGP 42446 |
| CGP-42'446 |
| CGP-42446 |
| CGP-42446A |
| CHEBI:46557 |
| CHEMBL924 |
| CS-1829 |
| CTK8A6898 |
| D08689 |
| D0VM2L |
| DB00399 |
| DSSTox_CID_22668 |
| DSSTox_GSID_42668 |
| DSSTox_RID_80065 |
| DTXSID0042668 |
| EBD33252 |
| FT-0082657 |
| FT-0601384 |
| GP9100 |
| GTPL3177 |
| HE004088 |
| HE299812 |
| HMS2089O09 |
| HS-0091 |
| HY-13777 |
| I06-0710 |
| JMC515594 Compound 55 |
| KB-62427 |
| KS-00000NZ4 |
| KS-1132 |
| LS-181815 |
| MCULE-1604726355 |
| MFCD00867791 |
| MolPort-002-885-874 |
| NCGC00159521-02 |
| NCGC00159521-03 |
| NCGC00159521-04 |
| NCGC00159521-05 |
| Novartis brand of zoledronic acid |
| 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- |
| Phosphonic acid, P,P'-[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 |
| 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 |
| Zomera (TN) |
| Zometa |
| Zometa (Novartis) |
| Zometa (TN) |
| Zometa Concentrate |
| Zometa, Zomera, Aclasta and Reclast, Zoledronic Acid |
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;IV (INFUSION) | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Novartis | RECLAST | zoledronic acid | INJECTABLE;IV (INFUSION) | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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;IV (INFUSION) | 021817-001 | Apr 16, 2007 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for RECLAST
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 0.05 mg/mL, 100 mL vial | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for RECLAST
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1591122 | ➤ Try a Free Trial |
| Taiwan | 200522969 | ➤ Try a Free Trial |
| Australia | 2001274109 | ➤ Try a Free Trial |
| European Patent Office | 1296689 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for RECLAST
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 174 | Luxembourg | ➤ Try a Free Trial | PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI |
| C/GB01/042 | United Kingdom | ➤ Try a Free 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 |
| 1591122/01 | Switzerland | ➤ Try a Free Trial | PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007 |
| C0035 | France | ➤ Try a Free Trial | PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
