Atelvia is a drug owned by Allergan Pharmaceuticals International Ltd. It is protected by 6 US drug patents filed in 2013. Out of these, 3 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 09, 2028. Details of Atelvia'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5583122 | Pharmaceutical compositions containing geminal diphosphonates |
Dec, 2013
(10 years ago) |
Expired
|
| US5622721 | Dosage forms of risedronate |
Apr, 2014
(10 years ago) |
Expired
|
|
US5583122 (Pediatric) | Pharmaceutical compositions containing geminal diphosphonates |
Jun, 2014
(10 years ago) |
Expired
|
| US8246989 | Dosage forms of bisphosphonates |
Jan, 2026
(1 year, 5 months from now) | Active |
| US7645460 | Dosage forms of risedronate |
Jan, 2028
(3 years from now) | Active |
| US7645459 | Dosage forms of bisphosphonates |
Jan, 2028
(3 years from now) | Active |
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 Atelvia's patents.
Latest Legal Activities on Atelvia's Patents
Given below is the list of recent legal activities going on the following patents of Atelvia.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2024 | US8246989 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jul, 2021 | US7645459 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jul, 2021 | US7645460 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Feb, 2020 | US8246989 (Litigated) |
| Post Issue Communication - Certificate of Correction | 09 Jan, 2013 | US8246989 (Litigated) |
| Recordation of Patent Grant Mailed | 21 Aug, 2012 | US8246989 (Litigated) |
| Patent Issue Date Used in PTA Calculation | 21 Aug, 2012 | US8246989 (Litigated) |
| Issue Notification Mailed | 01 Aug, 2012 | US8246989 (Litigated) |
| Dispatch to FDC | 26 Jul, 2012 | US8246989 (Litigated) |
| Mail Miscellaneous Communication to Applicant | 17 Jul, 2012 | US8246989 (Litigated) |
FDA has granted several exclusivities to Atelvia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Atelvia, 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 Atelvia.
Exclusivity Information
Atelvia holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Atelvia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Oct 08, 2013 |
Several oppositions have been filed on Atelvia'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 Atelvia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Atelvia patents.
Atelvia's oppositions filed in EPO
Atelvia has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 22, 2011, by Apotex Inc.. This opposition was filed on patent number EP05735411A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP05735411A | Mar, 2011 | APOTEX INC. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Atelvia 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 Atelvia's family patents as well as insights into ongoing legal events on those patents.
Atelvia's family patents
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Generic Launch
Generic Release Date:
Atelvia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 09, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Atelvia Generics:
Risedronate Sodium is the generic name for the brand Atelvia. 11 different companies have already filed for the generic of Atelvia, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Atelvia's generic
How can I launch a generic of Atelvia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Atelvia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Atelvia'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 Atelvia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 35 mg | 09 Jun, 2011 | 1 | 18 May, 2015 | 09 Jan, 2028 | Deferred |
About Atelvia
Atelvia is a drug owned by Allergan Pharmaceuticals International Ltd. It is used for treating osteoporosis in postmenopausal women. Atelvia uses Risedronate Sodium as an active ingredient. Atelvia was launched by Apil in 2010.
Market Authorisation Date:
Atelvia was approved by FDA for market use on 08 October, 2010.
Active Ingredient:
Atelvia uses Risedronate Sodium as the active ingredient. Check out other Drugs and Companies using Risedronate Sodium ingredient
Treatment:
Atelvia is used for treating osteoporosis in postmenopausal women.
Dosage:
Atelvia is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 35MG | TABLET, DELAYED RELEASE | Prescription | ORAL |