Actonel Patent Expiration

Actonel is a drug owned by Allergan Pharmaceuticals International Ltd. It is protected by 16 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 06, 2023. Details of Actonel's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7718634

(Pediatric)

Method of treatment using bisphosphonic acid
Nov, 2023

(11 months ago)

Expired
US7192938

(Pediatric)

Method of treatment using bisphosphonic acid
Nov, 2023

(11 months ago)

Expired
US7192938 Method of treatment using bisphosphonic acid
May, 2023

(1 year, 5 months ago)

Expired
US7718634 Method of treatment using bisphosphonic acid
May, 2023

(1 year, 5 months ago)

Expired
US6465443

(Pediatric)

Method for inhibiting bone resorption
Feb, 2019

(5 years ago)

Expired
US6432932

(Pediatric)

Method for inhibiting bone resorption
Jan, 2019

(5 years ago)

Expired
US6015801

(Pediatric)

Method for inhibiting bone resorption
Jan, 2019

(5 years ago)

Expired
US5994329

(Pediatric)

Method for inhibiting bone resorption
Jan, 2019

(5 years ago)

Expired
US6165513

(Pediatric)

Film-coated tablet for improved upper gastrointestinal tract safety
Dec, 2018

(5 years ago)

Expired
US6465443 Method for inhibiting bone resorption
Aug, 2018

(6 years ago)

Expired
US6432932 Method for inhibiting bone resorption
Jul, 2018

(6 years ago)

Expired
US6015801 Method for inhibiting bone resorption
Jul, 2018

(6 years ago)

Expired
US5994329 Method for inhibiting bone resorption
Jul, 2018

(6 years ago)

Expired
US6165513 Film-coated tablet for improved upper gastrointestinal tract safety
Jun, 2018

(6 years ago)

Expired
US5583122

(Pediatric)

Pharmaceutical compositions containing geminal diphosphonates
Jun, 2014

(10 years ago)

Expired
US5583122 Pharmaceutical compositions containing geminal diphosphonates
Dec, 2013

(10 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Actonel's patents.

Given below is the list of recent legal activities going on the following patents of Actonel.

Activity Date Patent Number
Patent litigations
Expire Patent 22 Apr, 2019 US7192938 (Litigated)
Maintenance Fee Reminder Mailed 05 Nov, 2018 US7192938 (Litigated)
Expire Patent 18 Jun, 2018 US7718634 (Litigated)
Maintenance Fee Reminder Mailed 01 Jan, 2018 US7718634 (Litigated)
Patent Issue Date Used in PTA Calculation 18 May, 2010 US7718634 (Litigated)
Recordation of Patent Grant Mailed 18 May, 2010 US7718634 (Litigated)
Issue Notification Mailed 28 Apr, 2010 US7718634 (Litigated)
Application Is Considered Ready for Issue 14 Apr, 2010 US7718634 (Litigated)
Dispatch to FDC 14 Apr, 2010 US7718634 (Litigated)
Issue Fee Payment Verified 01 Apr, 2010 US7718634 (Litigated)


FDA has granted several exclusivities to Actonel. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Actonel, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Actonel.

Exclusivity Information

Actonel holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Actonel's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-61) Jul 23, 2012
Pediatric Exclusivity(PED) Jan 23, 2013

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Several oppositions have been filed on Actonel's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Actonel's generic, the next section provides detailed information on ongoing and past EP oppositions related to Actonel patents.

Actonel's Oppositions Filed in EPO

Actonel has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 29, 2008, by Ratiopharm Gmbh. This opposition was filed on patent number EP03722591A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP07014362A Jun, 2018 ALIUD PHARMA GmbH / STADA Arzneimittel GmbH Revoked
EP07014362A Oct, 2015 Hexal AG Revoked
EP07014362A Oct, 2015 Gedeon Richter Plc. Revoked
EP07014362A Oct, 2015 Actavis Group PTC EHF Revoked
EP07014362A Oct, 2015 Generica Ilac Sanayi ve Ticaret A.S. Revoked
EP07014362A Jun, 2015 Agrobiogen GmbH Biotechnologie Revoked
EP07014362A Feb, 2015 Laboratorios Liconsa, S.A. Revoked
EP07014362A Jan, 2015 Synthon BV Revoked
EP07014362A Jan, 2015 Avansor Pharma Oy Revoked
EP07014362A Jan, 2015 G. L. Pharma GmbH Revoked
EP07014362A Jan, 2015 Glenmark Pharmaceuticals s.r.o. Revoked
EP07014362A Jan, 2015 Stada-Arzneimittel Aktiengesellschaft Revoked
EP03722591A Feb, 2011 Sandoz FarmacĂȘutica, Lda. Revoked
EP03722591A Jul, 2008 Gedeon Richter Plc. Revoked
EP03722591A Jul, 2008 PLIVA HRVATSKA d.o.o. Revoked
EP03722591A Jul, 2008 Generics [UK] Limited Revoked
EP03722591A Jul, 2008 Synthon BV Revoked
EP03722591A Jul, 2008 Teva Pharmaceutical Industries Ltd. et al. Revoked
EP03722591A Jul, 2008 ALFRED, E. TIEFENBACHER GMBH & CO. KG Revoked
EP03722591A Jul, 2008 Laboratorios Liconsa, S.A. Revoked
EP03722591A May, 2008 Ratiopharm GmbH Revoked


US patents provide insights into the exclusivity only within the United States, but Actonel is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Actonel's family patents as well as insights into ongoing legal events on those patents.

Actonel's Family Patents

Actonel has patent protection in a total of 32 countries. It's US patent count contributes only to 7.5% of its total global patent coverage. 20 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Actonel.

Family Patents

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Generic Launch

Generic Release Date:

Actonel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 06, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Actonel Generics:

Risedronate Sodium is the generic name for the brand Actonel. 11 different companies have already filed for the generic of Actonel, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Actonel's generic

How can I launch a generic of Actonel before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Actonel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Actonel's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Actonel -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
5 mg, 30 mg and 35 mg 23 Apr, 2004 1 05 Oct, 2007 Eligible
75 mg 07 Sep, 2007 1 10 Jun, 2018 Extinguished
150 mg 12 Aug, 2008 1 13 Jun, 2014 06 May, 2023 Extinguished

Alternative Brands for Actonel

Actonel which is used for prevention and treatment of osteoporosis, including in postmenopausal women, as well as for treating Paget's disease., has several other brand drugs in the same treatment category and using the same active ingredient (Risedronate Sodium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Apil
Atelvia

(uses Risedronate Sodium)

Used for treating osteoporosis in postmenopausal women.
Lilly
Evista Used for preventing and treating osteoporosis in postmenopausal women and inhibiting bone resorption, as well as for preventing breast cancer.
Sandoz
Reclast used for increasing bone mass and treating osteoporosis in postmenopausal women and men.
Warner Chilcott
Actonel With Calcium (copackaged)

(uses Risedronate Sodium)

used for preventing and treating osteoporosis in postmenopausal women.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Risedronate Sodium, Actonel's active ingredient. Check the complete list of approved generic manufacturers for Actonel





About Actonel

Actonel is a drug owned by Allergan Pharmaceuticals International Ltd. It is used for prevention and treatment of osteoporosis, including in postmenopausal women, as well as for treating Paget's disease. Actonel uses Risedronate Sodium as an active ingredient. Actonel was launched by Apil in 2000.

Approval Date:

Actonel was approved by FDA for market use on 14 April, 2000.

Active Ingredient:

Actonel uses Risedronate Sodium as the active ingredient. Check out other Drugs and Companies using Risedronate Sodium ingredient

Treatment:

Actonel is used for prevention and treatment of osteoporosis, including in postmenopausal women, as well as for treating Paget's disease.

Dosage:

Actonel is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
150MG TABLET Prescription ORAL
35MG TABLET Prescription ORAL
30MG TABLET Discontinued ORAL
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
5MG TABLET Discontinued ORAL