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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 patent protection?
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.Ibandronate sodium has one hundred and fourteen patent family members in forty countries.
There are sixteen drug master file entries for ibandronate sodium. Thirteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ibandronate sodium
| International Patents: | 114 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 15 |
| NDAs: | 17 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 13 |
| Bulk Api Vendors: | 150 |
| Clinical Trials: | 4 |
| Patent Applications: | 6,931 |
| 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
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orchid Hlthcare | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078998-001 | Mar 19, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Apotex Inc | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078948-001 | Mar 19, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Apotex Inc | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 204222-001 | Oct 16, 2015 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| 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 | 021455-001 | May 16, 2003 | ➤ Sign Up | ➤ Sign Up |
| Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | ➤ Sign Up | ➤ Sign Up |
| Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | ➤ Sign Up | ➤ Sign Up |
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | ➤ Sign Up | ➤ Sign Up |
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ibandronate sodium
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200404553 | ➤ Sign Up |
| China | 1646193 | ➤ Sign Up |
| Japan | 2010116408 | ➤ Sign Up |
| Hungary | 226457 | ➤ Sign Up |
| European Patent Office | 1117412 | ➤ Sign Up |
| Yugoslavia | 20501 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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