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
(1 year, 6 months ago) |
Expired
|
|
US7192938 (Pediatric) | Method of treatment using bisphosphonic acid |
Nov, 2023
(1 year, 6 months ago) |
Expired
|
| US7192938 | Method of treatment using bisphosphonic acid |
May, 2023
(2 years ago) |
Expired
|
| US7718634 | Method of treatment using bisphosphonic acid |
May, 2023
(2 years ago) |
Expired
|
|
US6465443 (Pediatric) | Method for inhibiting bone resorption |
Feb, 2019
(6 years ago) |
Expired
|
|
US6432932 (Pediatric) | Method for inhibiting bone resorption |
Jan, 2019
(6 years ago) |
Expired
|
|
US6015801 (Pediatric) | Method for inhibiting bone resorption |
Jan, 2019
(6 years ago) |
Expired
|
|
US5994329 (Pediatric) | Method for inhibiting bone resorption |
Jan, 2019
(6 years ago) |
Expired
|
|
US6165513 (Pediatric) | Film-coated tablet for improved upper gastrointestinal tract safety |
Dec, 2018
(6 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
(11 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent Critical | 22 Apr, 2019 | US7192938 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 05 Nov, 2018 | US7192938 (Litigated) |
| Expire Patent Critical | 18 Jun, 2018 | US7718634 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 01 Jan, 2018 | US7718634 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 18 May, 2010 | US7718634 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 18 May, 2010 | US7718634 (Litigated) |
| Issue Notification Mailed Critical | 28 Apr, 2010 | US7718634 (Litigated) |
| Application Is Considered Ready for Issue Critical | 14 Apr, 2010 | US7718634 (Litigated) |
| Dispatch to FDC | 14 Apr, 2010 | US7718634 (Litigated) |
| Issue Fee Payment Verified Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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 Farmacêutica, 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
| |||
| Lilly |
| |||
| Sandoz |
| |||
| Warner Chilcott |
| |||
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 |