ATELVIA Drug Patent Profile
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When do Atelvia patents expire, and what generic alternatives are available?
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.
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: | 3,924 |
Formulation / Manufacturing: | see details |
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 |
National Cancer Institute (NCI) | Phase 2 |
Wake Forest University Health Sciences | 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: ⤷ 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 |
---|---|---|---|
South Korea | 101411117 | ⤷ Try a Trial | |
European Patent Office | 0186405 | PHARMACEUTICAL COMPOSITIONS CONTAINING GEMINAL DIPHOSPHONATES | ⤷ Try a Trial |
New Zealand | 561708 | Dosage forms of risedronate | ⤷ 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 | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |