ATELVIA Drug Patent Profile
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When do Atelvia patents expire, and when can generic versions of Atelvia launch?
Atelvia is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-four patent family members in thirty-three countries.
The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Atelvia
A generic version of ATELVIA was approved as risedronate sodium by TEVA PHARMS USA on October 5th, 2007.
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Questions you can ask:
- What is the 5 year forecast for ATELVIA?
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Summary for ATELVIA
| International Patents: | 84 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 2 |
| Patent Applications: | 3,918 |
| Drug Prices: | Drug price information for ATELVIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ATELVIA |
| What excipients (inactive ingredients) are in ATELVIA? | ATELVIA excipients list |
| DailyMed Link: | ATELVIA at DailyMed |
Recent Clinical Trials for ATELVIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Phase 3 |
| Wake Forest University Health Sciences | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
Pharmacology for ATELVIA
| Drug Class | Bisphosphonate |
Paragraph IV (Patent) Challenges for ATELVIA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ATELVIA | Delayed-release Tablets | risedronate sodium | 35 mg | 022560 | 1 | 2011-06-09 |
US Patents and Regulatory Information for ATELVIA
ATELVIA is protected by three US patents.
Patents protecting ATELVIA
Dosage forms of bisphosphonates
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
Dosage forms of risedronate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
Dosage forms of bisphosphonates
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 |
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 |
International Patents for ATELVIA
See the table below for patents covering ATELVIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 587774 | ⤷ Sign Up | |
| Japan | 2798666 | ⤷ Sign Up | |
| Israel | 77243 | Pharmaceutical compositions containing geminal diphosphonic acid compounds and certain such novel compounds | ⤷ Sign Up |
| San Marino | P200700047 | ⤷ Sign Up | |
| Australia | 2008202652 | ⤷ Sign Up | |
| Australia | 5153485 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ATELVIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0186405 | C300031 | Netherlands | ⤷ Sign Up | PRODUCT NAME: RISEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF FARMACEUTISCH AANVAARDBARE ESTER, IN HET BIJZONDER NATRIUMRISEDRONAAT; NAT REGISTRATION NO/DATE: RVG 24990 20000609; FIRST REGISTRATION: SE 15290 - 15297 19991007 |
| 0186405 | 2000C/028 | Belgium | ⤷ Sign Up | PRODUCT NAME: NATRIUMRISEDRONAAT; NAT. REGISTRATION NO/DATE: 354 IS 498 F3 20000508; FIRST REGISTRATION: SE 15290 19991007 |
| 0186405 | SPC/GB00/021 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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