Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fuji
Merck
Daiichi Sankyo
Colorcon
Baxter
QuintilesIMS
Accenture
Dow

Generated: June 21, 2018

DrugPatentWatch Database Preview

ACTONEL Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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 seven patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and ninety-eight patent family members in forty-nine countries.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and seventy-five 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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

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 ➤ 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 020835-002 Apr 14, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for ACTONEL
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 150 mg ➤ Subscribe 2008-08-12
➤ Subscribe Tablets 35 mg; 500 mg ➤ Subscribe 2007-12-18
➤ Subscribe Tablets 75 mg ➤ Subscribe 2007-09-10
➤ Subscribe Tablets 5 mg, 30 mg and 35 mg ➤ Subscribe 2004-04-23

Non-Orange Book US Patents for ACTONEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety ➤ Sign Up
6,225,294 Method for inhibiting bone resorption ➤ Sign Up
6,544,967 Method for inhibiting bone resorption ➤ Sign Up
7,410,957 Method of treatment using bisphosphonic acid ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for ACTONEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00045 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
364 Luxembourg ➤ Sign Up 91364, EXPIRES: 20200826
00292 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
1175904/01 Switzerland ➤ Sign Up FORMER OWNER: SCHERING CORPORATION, US
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Dow
McKinsey
Chubb
Federal Trade Commission
UBS
Colorcon
Merck
Cantor Fitzgerald

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 verifification 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.