Atelvia Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7645460 Dosage forms of risedronate
Jan, 2028

(3 years from now)

Active
US7645459 Dosage forms of bisphosphonates
Jan, 2028

(3 years from now)

Active
US8246989 Dosage forms of bisphosphonates
Jan, 2026

(1 year, 1 month from now)

Active
US5583122

(Pediatric)

Pharmaceutical compositions containing geminal diphosphonates
Jun, 2014

(10 years ago)

Expired
US5622721 Dosage forms of risedronate
Apr, 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 Atelvia's patents.

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

Activity Date Patent Number
Patent litigations
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

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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
Patent litigations
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

Atelvia has patent protection in a total of 33 countries. It's US patent count contributes only to 21.6% of its total global patent coverage. 5 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 Atelvia.

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 Generic API suppliers:

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

Alternative Brands for Atelvia

Atelvia which is used for treating osteoporosis in postmenopausal women., 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
Actonel

(uses Risedronate Sodium)

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

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Risedronate Sodium. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Warner Chilcott
Actonel With Calcium (copackaged)


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





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.

Approval 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