Reclast is a drug owned by Sandoz Inc. It is protected by 5 US drug patents filed in 2013. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 05, 2028. Details of Reclast'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). | |||
|
US7932241 (Pediatric) | Pharmaceutical products comprising bisphosphonates |
Aug, 2028
(3 years from now) | Active |
| US7932241 | Pharmaceutical products comprising bisphosphonates |
Feb, 2028
(3 years from now) | Active |
| US8052987 | Method of administering bisphosphonates |
Oct, 2023
(1 year, 20 days ago) |
Expired
|
|
US4939130 (Pediatric) | Substituted alkanediphosphonic acids and pharmaceutical use |
Mar, 2013
(11 years ago) |
Expired
|
| US4939130 | Substituted alkanediphosphonic acids and pharmaceutical use |
Sep, 2012
(12 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 Reclast's patents.
Latest Legal Activities on Reclast's Patents
Given below is the list of recent legal activities going on the following patents of Reclast.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Apr, 2023 | US8052987 (Litigated) |
| Expire Patent Critical | 03 Jun, 2019 | US7932241 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Apr, 2019 | US8052987 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 17 Dec, 2018 | US7932241 |
| Recordation of Patent Grant Mailed Critical | 08 Nov, 2011 | US8052987 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 08 Nov, 2011 | US8052987 (Litigated) |
| Issue Notification Mailed Critical | 19 Oct, 2011 | US8052987 (Litigated) |
| Dispatch to FDC | 03 Oct, 2011 | US8052987 (Litigated) |
| Application Is Considered Ready for Issue Critical | 15 Sep, 2011 | US8052987 (Litigated) |
| Issue Fee Payment Verified Critical | 13 Sep, 2011 | US8052987 (Litigated) |
FDA has granted several exclusivities to Reclast. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Reclast, 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 Reclast.
Exclusivity Information
Reclast holds 3 exclusivities. All of its exclusivities have expired in 2012. Details of Reclast's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-581) | Dec 19, 2011 |
| New Indication(I-584) | Mar 15, 2012 |
| New Indication(I-595) | May 29, 2012 |
Several oppositions have been filed on Reclast'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 Reclast's generic, the next section provides detailed information on ongoing and past EP oppositions related to Reclast patents.
Reclast's Oppositions Filed in EPO
Reclast has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 18, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP05012711A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP05012711A | Jun, 2013 | Taylor Wessing LLP | Revoked |
| EP05012711A | Jun, 2013 | Sanovel IIaç San. ve Tic. A.S. | Revoked |
| EP05012711A | Jun, 2013 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP05012711A | Jun, 2013 | Actavis PTC ehf | Revoked |
| EP05012711A | Mar, 2013 | Generics [UK] Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Reclast 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 Reclast's family patents as well as insights into ongoing legal events on those patents.
Reclast's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Reclast's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 05, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Reclast Generic API suppliers:
Zoledronic Acid is the generic name for the brand Reclast. 26 different companies have already filed for the generic of Reclast, with Mylan Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Reclast's generic
How can I launch a generic of Reclast before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Reclast's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Reclast'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 Reclast -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.05 mg/mL, 100 mL vial | 29 Aug, 2008 | 1 | 02 Sep, 2012 | Extinguished |
Alternative Brands for Reclast
Reclast which is used for increasing bone mass and treating osteoporosis in postmenopausal women and men., has several other brand drugs in the same treatment category and using the same active ingredient (Zoledronic Acid). 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 |
| |||||
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. Zoledronic Acid. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Novartis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Zoledronic Acid, Reclast's active ingredient. Check the complete list of approved generic manufacturers for Reclast
About Reclast
Reclast is a drug owned by Sandoz Inc. It is used for increasing bone mass and treating osteoporosis in postmenopausal women and men. Reclast uses Zoledronic Acid as an active ingredient. Reclast was launched by Sandoz in 2007.
Approval Date:
Reclast was approved by FDA for market use on 16 April, 2007.
Active Ingredient:
Reclast uses Zoledronic Acid as the active ingredient. Check out other Drugs and Companies using Zoledronic Acid ingredient
Treatment:
Reclast is used for increasing bone mass and treating osteoporosis in postmenopausal women and men.
Dosage:
Reclast is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE/100ML | INJECTABLE | Prescription | INTRAVENOUS |