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Last Updated: March 19, 2024

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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Drug patent expirations by year for ATELVIA
Drug Prices for ATELVIA

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Drug Sales Revenue Trends for ATELVIA

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Recent Clinical Trials for ATELVIA

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SponsorPhase
Wake Forest University Health SciencesPhase 3
Wake Forest University Health SciencesPhase 2
National Cancer Institute (NCI)Phase 2

See all ATELVIA clinical trials

Pharmacology for ATELVIA
Drug ClassBisphosphonate
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN

Dosage forms of risedronate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN

Dosage forms of bisphosphonates
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 2269584 Formes orales entériques solides de dosage d'un diphosphonate avec un agent chelatant (Enteric solid oral dosage form of a bisphosphonate containing a chelating agent) ⤷  Try a Trial
South Korea 101070205 ⤷  Try a Trial
Spain 2349584 ⤷  Try a Trial
South Korea 20120104446 ENTERIC SOLID ORAL DOSAGE FORM OF BISPHOSPHONATE CONTAINING A CHELATING AGENT ⤷  Try a Trial
>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 ⤷  Try a Trial 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 SPC/GB00/021 United Kingdom ⤷  Try a Trial 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
0186405 2000C/028 Belgium ⤷  Try a Trial PRODUCT NAME: NATRIUMRISEDRONAAT; NAT. REGISTRATION NO/DATE: 354 IS 498 F3 20000508; FIRST REGISTRATION: SE 15290 19991007
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.