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Generated: September 22, 2018

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ACTONEL Drug 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. There are seven patents protecting this drug and four Paragraph IV challenges.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and seventy-seven 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
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Synonyms for ACTONEL
(1-hydroxy-2-(3-pyridinyl)ethylidene)-bis(phosphonic acid) monosodium salt
[1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic Acid Monosodium Salt
1-hydroxy-1-[hydroxy(sodiooxy)phosphoryl]-2-(pyridin-3-yl)ethylphosphonic acid
1-hydroxy-2-(3-pyridinyl) ethylidene bis-phosphonic acid monosodium salt
105462-24-6 (Parent)
115436-72-1
122458-82-6
2-(3-Pyridinyl)-2-hydroxyethylidene-1,1-bisphosphonate
934544-85-1
AB01274790-01
AB09807
AB2000101
AC-20120
AC-732
AC1N5G27
AC1Q1VB7
Acrel
ACT03362
AKOS015833432
AN-15580
API0004080
AS-13309
BB_SC-1157
C7H10NNaO7P2
C7H10NO7P2.Na
CCG-213235
CHEBI:8868
CHEMBL1654
CPD000469279
CS0033
CTK8F0842
D00942
DRFDPXKCEWYIAW-UHFFFAOYSA-M
FT-0631078
H864
HE298537
Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate (Na+)
I02-0324
J10129
K-1095
LS-106650
M2289
MFCD00867080
MFCD01706268
Monosodium (1-hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonate
Monosodium 1-Hydroxy-2-(3-pyridyl)ethylidene-1,1-diphosphonate
Monosodium Risedronate
Monosodium Risedronate Hemipentahydrate
NCGC00346521-01
NE 58095
OFG5EXG60L
Optinate
Optinate Septimum
P,P'-[1-Hydroxy-2-(3-pyridonyl)ethylidene]bis-phosphonic acid sodium salt
Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, disodium salt
Phosphonic acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, monosodium salt
Phosphonic acid, (2-hydroxy-2-(3-pyridinyl)ethylidene)bis-, disodium salt
Q-201723
RISEDREMATE SODIUM
Risedronate (sodium)
RISEDRONATE NA
Risedronate sodium
Risedronate sodium (USP)
Risedronate sodium [USAN:USP]
Risedronate sodium [USAN]
Risedronate sodium salt
Risedronic acid monosodium salt
RISEDRONIC ACID SODIUM
Risedronic acid sodium salt
risedronic acid, monosodium salt
RISEDRONIC ACID, SODIUM SALT
RTC-070962
s1428
SAM001246537
SCHEMBL18377
sodium hydrogen (1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate
sodium hydrogen(1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate
sodium hydroxy-(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphinate
sodium hydroxy-[1-hydroxy-1-phosphono-2-(3-pyridyl)ethyl]phosphinate
SODIUM HYDROXY-1-HYDROXY-1-PHOSPHONO-2-(PYRIDIN-3-YL)ETHYLPHOSPHINATE
Sodium risedronate
Sodium trihydrogen (1-hydroxy-2-(3-pyridyl)ethylidene)diphosphonate
TC-070962
UNII-OFG5EXG60L

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 Y ➤ 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 Y ➤ 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 Y ➤ 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 020835-002 Apr 14, 2000 ➤ 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
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ➤ 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00045 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
2006 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
364 Luxembourg ➤ Try a Free Trial 91364, EXPIRES: 20200826
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
US Army
Queensland Health
Merck
Teva
Colorcon
UBS
Healthtrust
Fuji

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