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Ibandronate sodium - Generic Drug Details
What are the generic drug sources for ibandronate sodium and what is the scope of ibandronate sodium freedom to operate?
Ibandronate sodium
is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Hoffmann La Roche, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharm Industries, and Watson Labs Teva, and is included in seventeen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for ibandronate sodium. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ibandronate sodium
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 15 |
| NDAs: | 17 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 14 |
| Bulk Api Vendors: | 146 |
| Clinical Trials: | 4 |
| Patent Applications: | 6,912 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ibandronate sodium |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ibandronate sodium |
| DailyMed Link: | ibandronate sodium at DailyMed |
Pharmacology for ibandronate sodium
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
Synonyms for ibandronate sodium
| (1-Hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonic acid |
| (1-Hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonicacid |
| (1-hydroxy-3-(methylpentylamino)propylidene)bisphosphonate |
| (1-Hydroxy-3-(methylpentylamino)propylidene)bisphosphonic acid sodium |
| (1-Hydroxy-3-(methylpentylamino)propylidene)bisphosphonic acid sodium hydrate |
| (1-Hydroxy-3-(methylpentylamino)propylidene)diphosphonic acid |
| [1 -Hydroxy-3-(methylpentylamino)-propylidene]bisphosphonic acid sodium salt |
| [1-Hydroxy-3- -propylidene]bisphosphonicacidsodiumsalt |
| [1-HYDROXY-3-(METHYL-PENTYL-AMINO)-1-PHOSPHONO-PROPYL]-PHOSPHONIC ACID |
| [1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphonic acid |
| [1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphonic acid |
| {1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl}phosphonic acid |
| 084I785 |
| 1-hydroxy-3-(methylpentylamino)propylidene bisphosphonic acid |
| 1-hydroxy-3-(methylpentylamino)propylidenebisphosphonate |
| 114084-78-5 |
| 138844-81-2 |
| 138926-19-9 |
| 23Y0B94E49 |
| 2467AH |
| AB0005104 |
| AB01275485-01 |
| ABP001087 |
| AC-521 |
| AC1L1U21 |
| AC1Q1W18 |
| AC1Q6RN2 |
| Acid ibandronico |
| ACT05524 |
| ACT05527 |
| AJ-77707 |
| AK120881 |
| AKOS015855723 |
| AKOS015994672 |
| AKOS025392160 |
| AKOS026750153 |
| AN-15797 |
| AN-31778 |
| AN-31785 |
| API0024527 |
| AS-12948 |
| BC219057 |
| BCP9000767 |
| BDBM12577 |
| BFQ |
| BG0654 |
| Bisphosphonate 2 |
| BM 21.0955 |
| BM 21.0955 . Na . H2O |
| BM 21.0955Na |
| BM 21.0955Na.H2O |
| BM 210955 |
| BM-21.0955 |
| BM-21.0955 monosodium salt monohydrate |
| BM-210955 |
| Bondenza |
| Bondronat |
| Bondronat (TN) |
| Boniva |
| Boniva (TN) |
| Bonviva |
| Bonviva (TN) |
| BRD-K08681769-323-01-1 |
| C9H22NO7P2.Na |
| C9H23NO7P2 |
| C9H24NNaO8P2 |
| CAS-138844-81-2 |
| CCG-213317 |
| CCG-220679 |
| CCG-222407 |
| CHEMBL1201008 |
| CHEMBL997 |
| CS-2725 |
| CS-2726 |
| CS-2727 |
| CT-064 |
| CTK8E7876 |
| CTK8E7877 |
| CTK8E7878 |
| D04486 |
| D08056 |
| D08SJZ |
| D0G9FL |
| DB00710 |
| Destara |
| DSSTox_CID_26618 |
| DSSTox_GSID_46618 |
| DSSTox_RID_81770 |
| DTXSID5048340 |
| DTXSID8046618 |
| EBD2156407 |
| FT-0602640 |
| FT-0627172 |
| GTPL3059 |
| H487 |
| HMS2090A13 |
| HMS3263M08 |
| HY-B0515 |
| HY-B0515A |
| HY-B0515B |
| Hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinic acid sodium salt monohydrate |
| I14-0821 |
| Ibandronate |
| Ibandronate (Sodium Monohydrate) |
| Ibandronate (Sodium) |
| Ibandronate sodium (USAN) |
| Ibandronate sodium [USAN:JAN] |
| Ibandronate sodium hydrate |
| Ibandronate sodium hydrate (JAN) |
| Ibandronate sodium monohydrate |
| Ibandronate sodium salt |
| Ibandronate sodium salt monohydrate |
| Ibandronate sodium salt, >=97% (NMR), solid |
| Ibandronic Acid |
| Ibandronic acid (INN) |
| Ibandronic acid [INN:BAN] |
| Ibandronic acid monosodium salt monohydrate |
| Ibandronic acid Na salt |
| Ibandronic Acid Sodium Salt |
| ibandronic acid, sodium salt, monohydrate |
| J-003052 |
| J-007183 |
| J-007198 |
| J12U072QL0 |
| JMC515594 Compound 53 |
| K-4496 |
| KB-205162 |
| KS-00000IT5 |
| KS-000013JD |
| KS-1071 |
| LP01103 |
| LP058979 |
| LP068287 |
| LP071868 |
| LS-183991 |
| LS-186539 |
| LS-187361 |
| LXLBEOAZMZAZND-UHFFFAOYSA-M |
| M-1207 |
| MFCD07197214 |
| MolPort-023-219-579 |
| MolPort-023-222-355 |
| Monosodium [1-hydroxy-3-(methylpentylamino)propane-1,1-diyl]diphosphonate monohydrate |
| MPBVHIBUJCELCL-UHFFFAOYSA-N |
| NCGC00167428-01 |
| NCGC00261788-01 |
| Phosphonic acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis- |
| Phosphonic acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-, monosodium salt |
| Phosphonic acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-, monosodium salt, monohydrate |
| Phosphonic acid, [1-hydroxy-3-(methylpentylamino)propylidene]bis- |
| R-484 |
| R484 |
| RG-484 |
| Ro-200-5450 |
| Roche brand of ibandronic acid, sodium salt, monohydrate |
| RPR 102289A |
| RPR-102289A |
| RT-013305 |
| RT-013306 |
| RTC-020914 |
| S0877 |
| SC-17206 |
| SCHEMBL1030768 |
| SCHEMBL1120210 |
| SCHEMBL9183 |
| sodium hydrate hydrogen {1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl}phosphonate |
| SODIUM HYDRATE HYDROGEN 1-HYDROXY-3-[METHYL(PENTYL)AMINO]-1-PHOSPHONOPROPYLPHOSPHONATE |
| sodium hydrogen (1-hydroxy-3-(methyl(pentyl)amino)-1-phosphonopropyl)phosphonate |
| sodium hydrogen (1-hydroxy-3-(methyl(pentyl)amino)-1-phosphonopropyl)phosphonate hydrate |
| SODIUM HYDROGEN 1-HYDROXY-3-[METHYL(PENTYL)AMINO]-1-PHOSPHONOPROPYLPHOSPHONATE |
| sodium hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphinate |
| sodium hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphono-propyl]phosphinate hydrate |
| Sodium Ibandronate |
| Sodium Trihydrogen (1-Hydroxy-3-(methylpenthylamino)propylidene)diphosphonate Monohydrate |
| Sodium trihydrogen (1-hydroxy-3-(methylpentylamino)propylidene)diphosphonate, monohydrate |
| sodium;hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinate;hydrate |
| SodiumIbandronate |
| ST24026059 |
| TC-020914 |
| TL8000885 |
| Tox21_112432 |
| Tox21_501103 |
| UMD7G2653W |
| UNII-23Y0B94E49 |
| UNII-J12U072QL0 |
| UNII-UMD7G2653W |
| Z2181651281 |
| ZINC1533877 |
Tentative approvals for IBANDRONATE SODIUM
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 2.5MG | TABLET; ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 1MG | INJECTABLE; INJECTION |
US Patents and Regulatory Information for ibandronate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 204502-001 | Mar 11, 2016 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | AB | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Sagent Pharms | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 202235-001 | Sep 2, 2014 | AP | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | AB | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ 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 ibandronate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ibandronate sodium
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2004129324 | ➤ Try a Free Trial |
| Germany | 69928819 | ➤ Try a Free Trial |
| South Korea | 20150053811 | ➤ Try a Free Trial |
| New Zealand | 556278 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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