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Alendronate sodium - Generic Drug Details
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What are the generic sources for alendronate sodium and what is the scope of alendronate sodium freedom to operate?
Alendronate sodium
is the generic ingredient in four branded drugs marketed by West-ward Pharms Int, Merck, Mission Pharma, Apotex, Aurobindo Pharma, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Neopharma, Sun Pharm, Teva Pharms, Upsher Smith Labs, Watson Labs, and Merck And Co Inc, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Alendronate sodium has one hundred and two patent family members in forty countries.
There are twenty-five drug master file entries for alendronate sodium. Twenty-six suppliers are listed for this compound.
Summary for alendronate sodium
| International Patents: | 102 |
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 16 |
| NDAs: | 18 |
| Drug Master File Entries: | 25 |
| Suppliers / Packagers: | 26 |
| Bulk Api Vendors: | 155 |
| Clinical Trials: | 24 |
| Patent Applications: | 7,746 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for alendronate sodium |
| Drug Sales Revenues: | Drug sales revenues for alendronate sodium |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for alendronate sodium |
| DailyMed Link: | alendronate sodium at DailyMed |
Pharmacology for alendronate sodium
| Drug Class | Bisphosphonate |
Medical Subject Heading (MeSH) Categories for alendronate sodium
Synonyms for alendronate sodium
| (4-amino-1-hydroxy-1-phosphono-butyl)phosphonic acid |
| (4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL)PHOSPHONIC ACI |
| (4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid |
| (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid Monosodium Salt |
| (4-amino-1-hydroxybutane-1,1-diyl)bis(phosphonic acid) |
| (4-amino-1-hydroxybutane-1,1-diyl)bisphosphonic acid |
| (4-Amino-1-hydroxybutane-1,1-diyl)diphosphonic acid |
| (4-Amino-1-Hydroxybutylidene)-Bisphosphonic Acid |
| (4-Amino-1-hydroxybutylidene)bisphosphonic acid |
| (4-Amino-1-hydroxybutylidene)bisphosphonic acid monosodium salt |
| (4-Amino-1-hydroxybutylidene)diphosphonic acid |
| (4-azanyl-1-oxidanyl-1-phosphono-butyl)phosphonic acid |
| 121268-17-5 |
| 121268-17-5 (mono-hydrochloride salt, trihydrate) |
| 129318-43-0 |
| 129318-43-0 (anhyd.) |
| 1yhm |
| 2UY4M2U3RA |
| 376A361 |
| 4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL PHOSPHONIC ACID |
| 4-Amino-1-hydroxy-1-phosphonobutyl phosphonic acid monosodium trihydrate |
| 4-amino-1-hydroxy-1-phosphonobutyl phosphonic acid, monosodium |
| 4-Amino-1-hydroxy-1,1-butylidinediphosphonic acid |
| 4-Amino-1-hydroxybutane-1,1-diphosphonate |
| 4-Amino-1-hydroxybutane-1,1-diphosphonic Acid |
| 4-amino-1-hydroxybutane-1,1-diyldiphosphonic acid |
| 4-Amino-1-hydroxybutylidene-1,1-bis(phosphonic acid) |
| 4-Amino-1-hydroxybutylidene-1,1-bisphosphonate |
| 4-amino-1-hydroxybutylidene-bisphosphonic acid |
| 4-Amino-1-hydroxybutylidine-1,1-bisphosphonate |
| 4-amino-1,1-diphosphonobutan-1-ol |
| 4988K7X26P |
| 66376-36-1 |
| 66376-36-1 (Parent) |
| 68549-EP2270008A1 |
| 68549-EP2292617A1 |
| 68549-EP2295426A1 |
| 68549-EP2295427A1 |
| 68549-EP2308855A1 |
| 70013-EP2292592A1 |
| 70013-EP2295409A1 |
| 70013-EP2305640A2 |
| 70013-EP2308479A2 |
| A805927 |
| A835441 |
| AB0008472 |
| AB0013933 |
| AB01274863-01 |
| AB09896 |
| AB10152 |
| ABDP |
| AC-8070 |
| AC1L1CW3 |
| AC1Q1W16 |
| AC1Q1W17 |
| Acide alendronique |
| Acide alendronique [INN-French] |
| Acido alendronico |
| Acido alendronico [INN-Spanish] |
| Acidum alendronicum |
| Acidum alendronicum [INN-Latin] |
| Adronat |
| AHBuBP |
| AHButBP |
| AHD |
| AJ-74282 |
| AK117216 |
| AK117569 |
| AKOS001015793 |
| AKOS015895071 |
| AKOS015960820 |
| AKOS016010492 |
| Alend |
| alendronate |
| Alendronate (Fosamax) |
| Alendronate (sodium hydrate) |
| Alendronate acid |
| ALENDRONATE MONOSODIUM SALT TRIHYDRATE |
| Alendronate monosodium trihydrate |
| Alendronate sodium (USAN) |
| Alendronate sodium [USAN:USP] |
| Alendronate sodium [USAN] |
| Alendronate sodium anhydrous |
| Alendronate sodium hydrate |
| Alendronate sodium hydrate (JP17) |
| ALENDRONATE SODIUM SALT TRIHYDRATE |
| Alendronate sodium trihydrate |
| Alendronate sodium trihydrate, >=97% (NMR), powder |
| Alendronate Sodium, Pharmaceutical Secondary Standard; Certified Reference Material |
| Alendronate sodium, United States Pharmacopeia (USP) Reference Standard |
| Alendronate, Sodium Salt |
| Alendronate, Sodium, Trihydrate |
| ALENDRONIC ACID |
| Alendronic acid (INN) |
| Alendronic acid [INN:BAN] |
| Alendronic Acid Monosodium Salt |
| Alendronic acid sodium salt |
| Alendronic acid, Sodium aldendronate |
| Alendros |
| Almerol |
| Aminohydroxybutylidene biphosphonate monosodium salt trihydrate |
| AN-32438 |
| AN-38504 |
| AN-8360 |
| ANW-43155 |
| ANW-43156 |
| API0001401 |
| API0005892 |
| Arendal |
| AS-10963 |
| Avalent |
| AX8002169 |
| AX8041220 |
| BB_SC-02791 |
| BCP22746 |
| BDBM25313 |
| BG0020 |
| BIDD:GT0180 |
| Binosto |
| Binosto (TN) |
| bisphosphonate |
| bisphosphonate, 65 |
| Bonalon |
| BPH 1 |
| BRD-K75527158-323-01-3 |
| C-15277 |
| C07752 |
| C4H12NNaO7P2 |
| C4H13NO7P2 |
| C4H18NNaO10P2 |
| CAKRAHQRJGUPIG-UHFFFAOYSA-M |
| CAS-121268-17-5 |
| CC-00619 |
| CCG-220631 |
| CHEBI:2566 |
| CHEBI:2567 |
| CHEMBL2367465 |
| CHEMBL675 |
| CHEMBL870 |
| CS-0431 |
| CTK8B3778 |
| CTK8B3779 |
| D00939 |
| D07119 |
| DB00630 |
| DCSBSVSZJRSITC-UHFFFAOYSA-M |
| Dronal |
| DS-2820 |
| DSSTox_CID_27778 |
| DSSTox_GSID_47801 |
| DSSTox_RID_82554 |
| DTXSID5022568 |
| DTXSID7047801 |
| Elandor |
| EX-101 |
| Fosalan |
| Fosamac |
| Fosamax |
| Fosamax (TN) |
| FT-0601586 |
| FT-0641064 |
| G-704,650 |
| G-704650 |
| GP1402 |
| GTH-42 |
| GTH-42J |
| GTH-42V |
| GTH-42W |
| GTPL3141 |
| HMS3604I12 |
| HMS3713P04 |
| HSCI1_000337 |
| HSDB 7990 |
| HY-11101 |
| Hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate (Na+) |
| I04-9842 |
| I06-0478 |
| I914 |
| Indrol |
| J-005667 |
| J10154 |
| J10298 |
| KS-00000L1S |
| KS-1028 |
| L-670452 |
| LS-106421 |
| LS-106423 |
| LS-106424 |
| M-1609 |
| MER-103 |
| MFCD00868112 |
| MFCD01748233 |
| MFCD01748233 (97%) |
| MK 217 |
| MK-0217 |
| MK-217 |
| Monosodium (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonate |
| Monosodium (4-amino-1-hydroxybutylidene)bisphosphonate trihydrate |
| Monosodium alendronate |
| NCGC00096054-01 |
| NCGC00096054-03 |
| NCGC00096054-04 |
| NCGC00263967-02 |
| NeoBon |
| OGSPWJRAVKPPFI-UHFFFAOYSA-N |
| Onclast |
| Oprea1_422906 |
| Osteovan |
| P,P'-(4-Amino-1-hydroxybutylidene)bis-phosphonic acid monosodium salt |
| P,P'-(4-Amino-1-hydroxybutylidene)bisphosphonic acid |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis- |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-, monosodium salt |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-, monosodium salt, trihydrate |
| Q-200606 |
| Q-200607 |
| RTR-003482 |
| SBI-0206778.P001 |
| SC-17297 |
| SC-22170 |
| SC-45997 |
| SCHEMBL18898 |
| SCHEMBL328770 |
| sodium (4-amino-1-hydroxy-1-phosphono-butyl)-hydroxy-phosphinate |
| sodium (4-amino-1-hydroxy-1-phosphono-butyl)-hydroxy-phosphinate trihydrate |
| sodium (4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate |
| sodium (4-azanyl-1-oxidanyl-1-phosphono-butyl)-oxidanyl-phosphinate |
| Sodium alendronate |
| Sodium alendronate hydrate |
| SODIUM ALENDRONATE TRIHYDRATE |
| Sodium alendronate trihydrate, European Pharmacopoeia (EP) Reference Standard |
| sodium alendronate(1-) |
| sodium hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate trihydrate |
| sodium hydrogen-4-amino-1-hydroxy-1-phosphonobutylphosphonate |
| sodium hydrogen(4-amino-1-hydroxy-1-phosphonobutyl)phosphonate |
| sodium trihydrate alendronate(1-) |
| sodium trihydrate hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate |
| Sodium trihydrogen (4-amino-1-hydroxybutylidene)diphosphonate, trihydrate |
| sodium trihydrogen 4-amino-1-hydroxybutylidenediphosphonate trihydrate |
| sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate;trihydrate |
| SPECTRUM1505166 |
| SR-05000001906 |
| SR-05000001906-1 |
| ST24034598 |
| ST2412625 |
| ST50036159 |
| Steovess |
| SY070842 |
| Teiroc |
| TL8000566 |
| Tox21_111553 |
| Tox21_111553_1 |
| TR-003482 |
| UNII-2UY4M2U3RA |
| UNII-4988K7X26P |
| UNII-X1J18R4W8P |
| VZ20111 |
| X1J18R4W8P |
| Y-8756 |
| Z56771118 |
| ZINC3801919 |
US Patents and Regulatory Information for alendronate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jubilant Cadista | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090557-001 | Feb 18, 2010 | AB | RX | No | No | Try a Free Trial | Try a Free Trial | Try a Free Trial | |||
| Mission Pharma | BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344-001 | Mar 12, 2012 | RX | Yes | Yes | Try a Free Trial | Try a Free Trial | Y | Y | Try a Free Trial | ||
| Cipla | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076768-004 | Aug 4, 2008 | AB | RX | No | No | Try a Free Trial | Try a Free Trial | Try a Free Trial | |||
| Sun Pharm | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090022-001 | Sep 10, 2008 | AB | RX | No | No | Try a Free Trial | Try a Free Trial | Try a Free Trial | |||
| Apotex | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 077982-001 | Aug 4, 2008 | AB | RX | No | No | 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 alendronate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | Try a Free Trial | Try a Free Trial |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | Try a Free Trial | Try a Free Trial |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | Try a Free Trial | Try a Free Trial |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | Try a Free Trial | Try a Free Trial |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | Try a Free Trial | Try a Free Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for alendronate sodium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 122006000009 | Try a Free Trial |
| Canada | 2349733 | Try a Free Trial |
| New Zealand | 508507 | Try a Free Trial |
| Australia | 2451102 | Try a Free Trial |
| Slovenia | 0998292 | Try a Free Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for alendronate sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | CA 2007 00045 | Denmark | Try a Free Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
| 1175904 | 91364 | Luxembourg | Try a Free Trial | 91364, EXPIRES: 20200826 |
| 1175904 | C01175904/01 | Switzerland | Try a Free Trial | FORMER OWNER: SCHERING CORPORATION, US |
| 0998292 | CA 2006 00005 | Denmark | Try a Free Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL |
| 0998292 | 91222 | Luxembourg | Try a Free Trial | 91222, EXPIRES: 20200824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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ISSN: 2162-2639
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DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.