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Generated: May 21, 2019

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ACTONEL Drug Profile

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When do Actonel patents expire, and what generic alternatives are available?

Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. There are six patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and sixty-four patent family members in forty-nine countries.

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.

Drug patent expirations by year for ACTONEL
Pharmacology for ACTONEL
Drug ClassBisphosphonate
Synonyms for ACTONEL
(1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid
(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphonic acid
(1-Hydroxy-2-(3-pyridyl)ethylidene)diphosphonic acid
(1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyl)bis(phosphonic acid)
(1-hydroxy-2-pyridin-3-ylethane-1,1-diyl)bis(phosphonic acid)
(1-oxidanyl-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid
[1-hydroxy-1-phosphono-2-(3-pyridinyl)ethyl]phosphonic acid
[1-hydroxy-1-phosphono-2-(3-pyridyl)ethyl]phosphonic acid
[1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonic acid
1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE BIS-PHOSPHONIC ACID
1-Hydroxy-2-(3-pyridyl)-ethan-1,1-bis-phosphonic acid
1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyldiphosphonic acid
105462-24-6
115436-72-1
115436-72-1 (mono-hydrochloride salt)
2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid
2689AH
462R246
A801245
AB0013898
AB01275490_02
AB01275490-01
AB2000344
AC-1295
AC1L1JX6
Acide risedroniqe
Acide risedronique
Acide risedronique [INN-French]
Acido risedronico
Acido risedronico [INN-Spanish]
Acidum risedronicum
Acidum risedronicum [INN-Latin]
Actonel 150
AKOS015892564
AN-15054
AS-13584
Atelvia
BC206977
BCP13805
BDBM12576
Benet
BIDD:GT0010
Bisphosphonate 1
C08233
C7H11NO7P2
C7H11NO7P2.H2O
CHEBI:8869
CHEMBL923
CS-1964
D08484
DB00884
DTXSID2023563
FT-0642593
GTPL3176
HMS2090C21
HSDB 7326
HY-B0148
I04-0049
I802
IIDJRNMFWXDHID-UHFFFAOYSA-N
JMC515594 Compound 64
KM2Z91756Z
KS-00000YSA
LS-171967
M-1366
NCGC00386377-01
NE 58019
NE-58095
Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-
Phosphonic acid, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-
PubChem14002
RESEDRONIC ACID
Ridron (TN)
RIS
Risdronate
Risedronate
Risedronate acid
Risedronic acid
Risedronic acid (Actonel)
Risedronic acid (INN)
Risedronic acid [INN:BAN]
Risedronic acid monohydrate
Risedronsaure
s1874
SC-14176
SCHEMBL18378
SR-05000001495
SR-05000001495-1
UNII-KM2Z91756Z
Z2684418685
ZINC1531009

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 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ACTONEL
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 150 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 35 mg; 500 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 75 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 5 mg, 30 mg and 35 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for ACTONEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0998292 91222 Luxembourg ➤ Try a Free Trial 91222, EXPIRES: 20200824
0998292 CA 2006 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
0998292 PA2006002,C0998292 Lithuania ➤ Try a Free Trial 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 91364 Luxembourg ➤ Try a Free Trial 91364, EXPIRES: 20200826
1175904 CA 2007 00045 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
1175904 C01175904/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
1175904 2007C/048 Belgium ➤ Try a Free Trial PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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