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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 has one hundred and two patent family members in forty countries.
There are twenty-five drug master file entries for alendronate sodium. Thirty-one 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: | 31 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 2,550 |
| Patent Applications: | 7,750 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upsher-smith Labs | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075871-001 | Apr 22, 2009 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Dr Reddys Labs Ltd | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 079049-001 | Aug 4, 2008 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Hangzhou Binjiang | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090258-001 | Sep 24, 2009 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Watson Labs | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076984-001 | Aug 4, 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 |
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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 | 020560-004 | Oct 20, 2000 | ➤ Sign Up | ➤ Sign Up |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | ➤ Sign Up | ➤ Sign Up |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for alendronate 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 |
|---|---|---|
| 6,465,443 | Method for inhibiting bone resorption | ➤ Sign Up |
| 6,333,316 | Method for inhibiting bone resorption | ➤ Sign Up |
| 6,544,967 | Method for inhibiting bone resorption | ➤ Sign Up |
| 8,449,906 | Effervescent compositions comprising phosphonates and methods related thereto | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for alendronate sodium
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 2451102 | ➤ Sign Up |
| Austria | 357921 | ➤ Sign Up |
| United Kingdom | 2336311 | ➤ Sign Up |
| Netherlands | 300223 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for alendronate sodium
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 1175904/01 | Switzerland | ➤ Sign Up | FORMER OWNER: SCHERING CORPORATION, US |
| 2007 00045 | Denmark | ➤ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
| 364 | Luxembourg | ➤ Sign Up | 91364, EXPIRES: 20200826 |
| 2006002 | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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