ACTONEL Drug Patent Profile
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When do Actonel patents expire, and when can generic versions of Actonel launch?
Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs.
The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.
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Summary for ACTONEL
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 35 |
Patent Applications: | 2,193 |
Drug Prices: | Drug price information for ACTONEL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACTONEL |
What excipients (inactive ingredients) are in ACTONEL? | ACTONEL excipients list |
DailyMed Link: | ACTONEL at DailyMed |
Recent Clinical Trials for ACTONEL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dong-A ST Co., Ltd. | Phase 4 |
Wake Forest University Health Sciences | Phase 3 |
Hospital for Special Surgery, New York | Phase 4 |
Pharmacology for ACTONEL
Drug Class | Bisphosphonate |
Paragraph IV (Patent) Challenges for ACTONEL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACTONEL | Tablets | risedronate sodium | 150 mg | 020835 | 1 | 2008-08-12 |
ACTONEL | Tablets | risedronate sodium | 75 mg | 020835 | 1 | 2007-09-07 |
ACTONEL | Tablets | risedronate sodium | 5 mg, 30 mg and 35 mg | 020835 | 1 | 2004-04-23 |
US Patents and Regulatory Information for ACTONEL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-001 | Mar 27, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Warner Chilcott | ACTONEL WITH CALCIUM (COPACKAGED) | calcium carbonate; risedronate sodium | TABLET;ORAL | 021823-001 | Aug 12, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-005 | Apr 22, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 ACTONEL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-005 | Apr 22, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTONEL
See the table below for patents covering ACTONEL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 039978 | TRATAMIENTO Y PREVENCION DE LA OSTEOPOROSIS | ⤷ Sign Up |
South Africa | 9805010 | ⤷ Sign Up | |
Slovenia | 1506041 | ⤷ Sign Up | |
Czech Republic | 9401230 | ⤷ Sign Up | |
European Patent Office | 1132088 | ⤷ Sign Up | |
Hungary | T67681 | ⤷ Sign Up | |
European Patent Office | 1151752 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTONEL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1175904 | 91364 | Luxembourg | ⤷ Sign Up | 91364, EXPIRES: 20200826 |
0186405 | 2000C/028 | Belgium | ⤷ Sign Up | PRODUCT NAME: NATRIUMRISEDRONAAT; NAT. REGISTRATION NO/DATE: 354 IS 498 F3 20000508; FIRST REGISTRATION: SE 15290 19991007 |
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 |
0998292 | CA 2006 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL |
1175904 | CA 2007 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
0998292 | 91222 | Luxembourg | ⤷ Sign Up | 91222, EXPIRES: 20200824 |
1175904 | PA2007007 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |