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Alendronate sodium - Generic Drug Details
What are the generic sources for alendronate sodium and what is the scope of alendronate sodium patent protection?
Alendronate sodium
is the generic ingredient in four branded drugs marketed by West-ward Pharms Int, Merck, Mission Pharma, Apotex, Aurobindo Pharma, Cipla Ltd, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Neopharma, Sun Pharma Global, 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.There are twenty-five drug master file entries for alendronate sodium. Twenty-eight suppliers are listed for this compound.
Summary for alendronate sodium
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 16 |
| NDAs: | 18 |
| Drug Master File Entries: | 25 |
| Suppliers / Packagers: | 28 |
| Bulk Api Vendors: | 150 |
| Clinical Trials: | 24 |
| Patent Applications: | 7,727 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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
| Ingredient-type | Diphosphonates |
| 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 (mono-hydrochloride salt, trihydrate) |
| 129318-43-0 |
| 1yhm |
| 376A361 |
| 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-DIYLDIPHOSPHONATE |
| 4-Amino-1-hydroxybutylidene-1,1-bis(phosphonic acid) |
| 4-Amino-1-hydroxybutylidene-1,1-bisphosphonate |
| 4-AMINO-1-HYDROXYBUTYLIDENE-1,1-BISPHOSPHONIC ACID MONOSODIUM SALT |
| 4-amino-1-hydroxybutylidene-bisphosphonic acid |
| 4-Amino-1-hydroxybutylidine-1,1-bisphosphonate |
| 4-amino-1,1-diphosphonobutan-1-ol |
| 4988K7X26P |
| 66376-36-1 |
| 68549-EP2270008A1 |
| 68549-EP2292617A1 |
| 68549-EP2295426A1 |
| 68549-EP2295427A1 |
| 68549-EP2308855A1 |
| 70013-EP2292592A1 |
| 70013-EP2295409A1 |
| 70013-EP2305640A2 |
| 70013-EP2308479A2 |
| A805927 |
| A835441 |
| AB0008472 |
| AB01274863-01 |
| AB10152 |
| ABDP |
| AC1L1CW3 |
| AC1Q1W16 |
| Acide alendronique |
| Acide alendronique [INN-French] |
| Acido alendronico |
| Acido alendronico [INN-Spanish] |
| Acidum alendronicum |
| Acidum alendronicum [INN-Latin] |
| AHBuBP |
| AHButBP |
| AHD |
| AJ-74282 |
| AK117216 |
| AKOS001015793 |
| AKOS015895071 |
| Alend |
| alendronate |
| Alendronate acid |
| Alendronate sodium anhydrous |
| 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 |
| Alendronic acid, Sodium aldendronate |
| Alendronicacid |
| Almerol |
| Aminohydroxybutane Bisphosphonate |
| AN-32438 |
| AN-38504 |
| ANW-43156 |
| API0001401 |
| API0005892 |
| Arendal |
| AS-10963 |
| Avalent |
| AX8002169 |
| BB_SC-02791 |
| BB_SC-2791 |
| BDBM25313 |
| BG0020 |
| BIDD:GT0180 |
| Binosto |
| bisphosphonate |
| bisphosphonate, 65 |
| Bonalon |
| BPH 1 |
| BRD-K75527158-323-01-3 |
| C-15277 |
| C07752 |
| C4H12NNaO7P2 |
| C4H13NO7P2 |
| CAKRAHQRJGUPIG-UHFFFAOYSA-M |
| CC-00619 |
| CCG-220631 |
| CHEBI:2567 |
| CHEMBL675 |
| CHEMBL870 |
| CTK8B3779 |
| D07119 |
| D09KLR |
| DB00630 |
| DTXSID5022568 |
| EX-101 |
| Fosamac |
| Fosamax |
| Fosamax (TN) |
| FT-0641064 |
| G-704650 |
| GTH-42 |
| GTH-42J |
| GTH-42V |
| GTH-42W |
| GTPL3141 |
| HMS3604I12 |
| HSCI1_000337 |
| HSDB 7990 |
| Hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate (Na+) |
| I04-9842 |
| I06-0478 |
| Indrol |
| J-005667 |
| J10298 |
| KS-1028 |
| L-670452 |
| LS-106421 |
| LS-106423 |
| M-1609 |
| MER-103 |
| MFCD00868112 |
| MFCD01861681 |
| MK 217 |
| MK-0217 |
| MK-217 |
| Monosodium (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonate |
| Monosodium alendronate |
| NCGC00096054-01 |
| NCGC00096054-03 |
| NCGC00096054-04 |
| NeoBon |
| OGSPWJRAVKPPFI-UHFFFAOYSA-N |
| Onclast |
| Oprea1_422906 |
| OR006545 |
| Osteovan |
| P,P'-(4-Amino-1-hydroxybutylidene)bis-phosphonic acid monosodium salt |
| P,P'-(4-Amino-1-hydroxybutylidene)bisphosphonic acid |
| PHOSPHONATE, (4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL)-, SODIUM SALT |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis- |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-, monosodium salt |
| Q-200607 |
| SBI-0206778.P001 |
| SC-17297 |
| SC-22170 |
| SCHEMBL18898 |
| SCHEMBL328770 |
| sodium (4-amino-1-hydroxy-1-phosphono-butyl)-hydroxy-phosphinate |
| sodium (4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate |
| sodium (4-azanyl-1-oxidanyl-1-phosphono-butyl)-oxidanyl-phosphinate |
| SODIUM ALDENDRONATE |
| Sodium alendronate |
| sodium alendronate(1-) |
| sodium hydrogen(4-amino-1-hydroxy-1-phosphonobutyl)phosphonate |
| SPECTRUM1505166 |
| ST24034598 |
| ST50036159 |
| Steovess |
| Teiroc |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-002 | Feb 6, 2008 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-003 | Feb 6, 2008 | AB | 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 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 | ➤ Sign Up | ➤ Sign Up |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ➤ Sign Up | ➤ Sign Up |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for alendronate sodium
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Croatia | P20000035 | ➤ Sign Up |
| South Korea | 20030097610 | ➤ Sign Up |
| Ukraine | 67748 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for alendronate sodium
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00292 | Netherlands | ➤ Sign Up | PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824 |
| 2006002,C0998292 | Lithuania | ➤ Sign Up | PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824 |
| 364 | Luxembourg | ➤ Sign Up | 91364, EXPIRES: 20200826 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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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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