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ATELVIA Drug Profile
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Which patents cover Atelvia, and when can generic versions of Atelvia launch?
This drug has seventy-six patent family members in thirty-one countries.
The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for ATELVIA
| International Patents: | 76 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 140 |
| Patent Applications: | 3,174 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ATELVIA |
| DailyMed Link: | ATELVIA at DailyMed |
Pharmacology for ATELVIA
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
Medical Subject Heading (MeSH) Categories for ATELVIA
Synonyms for ATELVIA
| (1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid |
| (1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphonic acid |
| (1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphonic acid; sodium |
| (1-hydroxy-2-(3-pyridinyl)ethylidene)-bis(phosphonic acid) monosodium salt |
| (1-Hydroxy-2-(3-pyridyl)ethylidene)diphosphonic acid |
| (1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyl)bis(phosphonic acid) |
| (1-hydroxy-2-pyridin-3-ylethane-1,1-diyl)bis(phosphonic acid) |
| (1-oxidanyl-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid |
| [1-hydroxy-1-phosphono-2-(3-pyridinyl)ethyl]phosphonic acid |
| [1-hydroxy-1-phosphono-2-(3-pyridyl)ethyl]phosphonic acid |
| [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonic acid |
| [1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic Acid Monosodium Salt |
| 1-hydroxy-1-[hydroxy(sodiooxy)phosphoryl]-2-(pyridin-3-yl)ethylphosphonic acid |
| 1-hydroxy-2-(3-pyridinyl) ethylidene bis-phosphonic acid monosodium salt |
| 1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE BIS-PHOSPHONIC ACID |
| 1-Hydroxy-2-(3-pyridyl)-ethan-1,1-bis-phosphonic acid |
| 105462-24-6 |
| 105462-24-6 (Parent) |
| 115436-72-1 |
| 115436-72-1 (mono-hydrochloride salt) |
| 122458-82-6 |
| 2-(3-Pyridinyl)-2-hydroxyethylidene-1,1-bisphosphonate |
| 2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid |
| 2689AH |
| 436R721 |
| 462R246 |
| 934544-85-1 |
| A801245 |
| AB0013898 |
| AB01274790-01 |
| AB01275490_02 |
| AB01275490-01 |
| AB09807 |
| AB2000101 |
| AB2000344 |
| AC-1295 |
| AC-20120 |
| AC-732 |
| AC1L1JX6 |
| AC1N5G27 |
| AC1O3LR2 |
| AC1Q1VB7 |
| Acide risedroniqe |
| Acide risedronique |
| Acide risedronique [INN-French] |
| Acido risedronico |
| Acido risedronico [INN-Spanish] |
| Acidum risedronicum |
| Acidum risedronicum [INN-Latin] |
| Acrel |
| ACT03362 |
| Actonel |
| Actonel (TN) |
| Actonel 150 |
| AK163014 |
| AK163015 |
| AKOS015833432 |
| AKOS015892564 |
| AKOS024462575 |
| AKOS030228065 |
| AN-15054 |
| AN-15580 |
| API0004080 |
| AS-13309 |
| AS-13584 |
| AX8017640 |
| BB_SC-1157 |
| BC206977 |
| BDBM12576 |
| Benet |
| BIDD:GT0010 |
| Bisphosphonate 1 |
| C08233 |
| C7H10NNaO7P2 |
| C7H10NO7P2.Na |
| C7H11NO7P2 |
| C7H11NO7P2.H2O |
| CCG-213235 |
| CHEBI:8868 |
| CHEBI:8869 |
| CHEMBL1654 |
| CHEMBL923 |
| CPD000469279 |
| CS-1964 |
| CS0033 |
| CTK8F0842 |
| D00942 |
| D08484 |
| D0I7IC |
| D0PA5S |
| DB00884 |
| DRFDPXKCEWYIAW-UHFFFAOYSA-M |
| DTXSID2023563 |
| FT-0631078 |
| FT-0642593 |
| GTPL3176 |
| H864 |
| HE004268 |
| HE292529 |
| HE298537 |
| HMS2090C21 |
| HSDB 7326 |
| HY-B0148 |
| Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate (Na+) |
| I02-0324 |
| I04-0049 |
| I802 |
| IIDJRNMFWXDHID-UHFFFAOYSA-N |
| J10129 |
| JMC515594 Compound 64 |
| K-1095 |
| KM2Z91756Z |
| KS-00000XMN |
| KS-00000YSA |
| LS-106650 |
| LS-171967 |
| M-1366 |
| M2289 |
| MFCD00867080 |
| MFCD01706268 |
| MolPort-044-724-030 |
| Monosodium (1-hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonate |
| Monosodium 1-Hydroxy-2-(3-pyridyl)ethylidene-1,1-diphosphonate |
| Monosodium Risedronate |
| Monosodium Risedronate Hemipentahydrate |
| NCGC00346521-01 |
| NE 58019 |
| NE 58095 |
| NE-58095 |
| OFG5EXG60L |
| Optinate |
| Optinate Septimum |
| P,P'-[1-Hydroxy-2-(3-pyridonyl)ethylidene]bis-phosphonic acid sodium salt |
| Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis- |
| Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, disodium salt |
| Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, monosodium salt |
| Phosphonic acid, (2-hydroxy-2-(3-pyridinyl)ethylidene)bis-, disodium salt |
| Phosphonic acid, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis- |
| PubChem14002 |
| Q-201723 |
| RESEDRONIC ACID |
| Ridron |
| Ridron (TN) |
| RIS |
| Risdronate |
| RISEDREMATE SODIUM |
| Risedronate |
| Risedronate (sodium) |
| RISEDRONATE NA |
| Risedronate sodium |
| Risedronate sodium (USP) |
| Risedronate sodium [USAN:USP] |
| Risedronate sodium [USAN] |
| risedronate sodium anhydrous |
| Risedronate sodium hydrate |
| Risedronate sodium monohydrate |
| Risedronate sodium salt |
| Risedronic acid |
| Risedronic acid (Actonel) |
| Risedronic acid (INN) |
| Risedronic acid [INN:BAN] |
| Risedronic acid monohydrate |
| Risedronic acid monosodium salt |
| RISEDRONIC ACID SODIUM |
| Risedronic acid sodium salt |
| risedronic acid, monosodium salt |
| RISEDRONIC ACID, SODIUM SALT |
| Risedronsaure |
| RTC-070962 |
| s1428 |
| s1874 |
| SAM001246537 |
| SC-14176 |
| SCHEMBL18377 |
| SCHEMBL18378 |
| SCHEMBL2115050 |
| sodium hydrogen (1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate |
| sodium hydrogen(1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate |
| sodium hydroxy-(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphinate |
| sodium hydroxy-[1-hydroxy-1-phosphono-2-(3-pyridyl)ethyl]phosphinate |
| SODIUM HYDROXY-1-HYDROXY-1-PHOSPHONO-2-(PYRIDIN-3-YL)ETHYLPHOSPHINATE |
| Sodium risedronate |
| sodium risedronate hydrate |
| Sodium trihydrogen (1-hydroxy-2-(3-pyridyl)ethylidene)diphosphonate |
| TC-070962 |
| UNII-KM2Z91756Z |
| UNII-OFG5EXG60L |
| Z2684418685 |
| ZINC1531009 |
US Patents and Regulatory Information for ATELVIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | 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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Expired US Patents for ATELVIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | ➤ Sign Up | ➤ Sign Up |
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for ATELVIA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Tablets | 35 mg | ➤ Subscribe | 2011-07-19 |
Non-Orange Book US Patents for ATELVIA
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 |
|---|---|---|
| 8,409,614 | Low dosage forms of risedronate or its salts | ➤ Sign Up |
| 8,535,718 | Dosage forms of bisphosphonates | ➤ Sign Up |
| 8,409,615 | Low dosage forms of risedronate or its salts | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ATELVIA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 2005330654 | ➤ Sign Up |
| Japan | 4605221 | ➤ Sign Up |
| South Korea | 20130063041 | ➤ Sign Up |
| Russian Federation | 2006140888 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
