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ATELVIA Drug Profile
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This drug has seventy-one 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. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the risedronate sodium profile page.
Summary for Tradename: ATELVIA
| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Drug Prices: : | see details |
Pharmacology for Tradename: ATELVIA
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
Clinical Trials for: ATELVIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | RX | Yes | 7,645,459 | Jan 9, 2028 | Y | |||||||||||||||||||
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | RX | Yes | 7,645,460 | Jan 9, 2028 | Y | |||||||||||||||||||
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | RX | Yes | 8,246,989 | Jan 16, 2026 | Y | |||||||||||||||||||
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Expired Patents for Tradename: ATELVIA
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| 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 | 5,583,122*PED | <disabled> | ||||||||||||||||||||||
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | 5,622,721 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: ATELVIA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| risedronate sodium | Delayed-release Tablets | 35 mg | Atelvia | 7/19/2011 |
Non-Orange Book Patents for Tradename: 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 | <disabled in preview> | |||||||||||||||||||||||||||
| 8,535,718 | Dosage forms of bisphosphonates | <disabled in preview> | |||||||||||||||||||||||||||
| 8,409,615 | Low dosage forms of risedronate or its salts | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: ATELVIA
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2269584 | <disabled in preview> | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2006112889 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2566798 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
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