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BINOSTO Drug Profile
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Which patents cover Binosto, and when can generic versions of Binosto launch?
This drug has eleven patent family members in seven countries.
The generic ingredient in BINOSTO is alendronate sodium. There are twenty-five drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for BINOSTO
| International Patents: | 11 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 30 |
| Clinical Trials: | 1 |
| Patent Applications: | 22 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | BINOSTO at DailyMed |
Pharmacology for BINOSTO
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
Medical Subject Heading (MeSH) Categories for BINOSTO
Synonyms for BINOSTO
| (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid Monosodium Salt |
| (4-Amino-1-hydroxybutylidene)bisphosphonic acid monosodium salt |
| 129318-43-0 |
| 4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL PHOSPHONIC ACID,MONOSODIUM |
| 4-AMINO-1-HYDROXYBUTYLIDENE-1,1-BISPHOSPHONIC ACID MONOSODIUM SALT |
| 4-Amino-1-hydroxybutylidine-1,1-bisphosphonate |
| 4988K7X26P |
| A805927 |
| AB10152 |
| AC1Q1W16 |
| AHBuBP |
| AHButBP |
| AKOS015895071 |
| Alend |
| ALENDRONATE SODIUM |
| Alendronate sodium anhydrous |
| Alendronate, Sodium Salt |
| Alendronate, Sodium, Trihydrate |
| Alendronic Acid Monosodium Salt |
| Alendronic acid sodium salt |
| ALENDRONIC ACID, SODIUM |
| Alendronic acid, Sodium aldendronate |
| Almerol |
| AN-32438 |
| API0001401 |
| Avalent |
| BB_SC-02791 |
| BB_SC-2791 |
| BG0020 |
| Bonalon |
| C4H12NNaO7P2 |
| CAKRAHQRJGUPIG-UHFFFAOYSA-M |
| CCG-220631 |
| CHEMBL675 |
| EX-101 |
| Fosamac |
| Fosamax |
| G-704650 |
| GTH-42 |
| GTH-42J |
| GTH-42V |
| GTH-42W |
| HMS3604I12 |
| Hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate (Na+) |
| I06-0478 |
| Indrol |
| J-005667 |
| KS-1028 |
| L-670452 |
| LS-106423 |
| MER-103 |
| MFCD00868112 |
| MFCD01861681 |
| MK 217 |
| MK-0217 |
| MK-217 |
| Monosodium (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonate |
| Monosodium alendronate |
| NeoBon |
| Onclast |
| Osteovan |
| P,P'-(4-Amino-1-hydroxybutylidene)bis-phosphonic acid monosodium salt |
| PHOSPHONATE, (4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL)-, SODIUM SALT |
| Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-, monosodium salt |
| SC-22170 |
| 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 |
| Steovess |
| Teiroc |
| UNII-4988K7X26P |
| Y-8756 |
US Patents and Regulatory Information for BINOSTO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mission Pharma | BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344-001 | Mar 12, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Mission Pharma | BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344-001 | Mar 12, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ 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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Non-Orange Book US Patents for BINOSTO
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 |
|---|---|---|
| 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 BINOSTO
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2448501 | ➤ Sign Up |
| Spain | 2380924 | ➤ Sign Up |
| Australia | 2003219999 | ➤ Sign Up |
| European Patent Office | 1490024 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
