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Ibandronate sodium - Generic Drug Details
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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. Fourteen 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: | 14 |
| Bulk Api Vendors: | 146 |
| Clinical Trials: | 4 |
| Patent Applications: | 6,916 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Industries | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078996-001 | Aug 15, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Accord Hlthcare | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 206058-001 | Feb 5, 2016 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Sagent Pharms | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 202235-001 | Sep 2, 2014 | 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 |
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Expired US Patents for ibandronate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for ibandronate sodium
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,627,221 | Pharmaceutical composition containing diphosphonic acid or salt thereof | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ibandronate sodium
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2763775 | ➤ Sign Up |
| South Korea | 20120065435 | ➤ Sign Up |
| Canada | 2346662 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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