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 | 020835-003 | May 25, 2002 | ⤷ 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 | 020835-003 | May 25, 2002 | ⤷ 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 | 020835-002 | Apr 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | ⤷ 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 |
|---|---|---|---|
| South Korea | 100642961 | ⤷ Sign Up | |
| New Zealand | 508507 | Method for inhibiting bone resorption | ⤷ Sign Up |
| Netherlands | 300292 | ⤷ Sign Up | |
| South Korea | 20030097610 | ⤷ Sign Up | |
| Australia | 7446098 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0115703 | ⤷ Sign Up | |
| Slovakia | 284690 | ⤷ 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 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 1175904 | C300292 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824 |
| 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 |
| 1175904 | C01175904/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: SCHERING CORPORATION, US |
| 0998292 | PA2006002,C0998292 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824 |
| 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 |
| 0998292 | PA2006002 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824 |
| >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.
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