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 5^th, 2007.

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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:	4,625
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

Drug patent expirations by year for ATELVIA

Recent Clinical Trials for ATELVIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Phase 3
National Cancer Institute (NCI)	Phase 2
Wake Forest University Health Sciences	Phase 2

See all ATELVIA clinical trials

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
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Patent Expiration: ⤷ Sign Up

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Glossary

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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

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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	⤷ 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.

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Country	Patent Number	Title	Estimated Expiration
Germany	602005022578		⤷ Sign Up
Brazil	PI0520082		⤷ Sign Up
Israel	268462	Dosage forms of risedronate	⤷ Sign Up
European Patent Office	2269584		⤷ Sign Up
European Patent Office	0186405	PHARMACEUTICAL COMPOSITIONS CONTAINING GEMINAL DIPHOSPHONATES	⤷ Sign Up
South Africa	200609446		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ATELVIA

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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