Reclast Patent Expiration

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

(11 months 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.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 26 Apr, 2023 US8052987 (Litigated)
Expire Patent 03 Jun, 2019 US7932241
Payment of Maintenance Fee, 8th Year, Large Entity 25 Apr, 2019 US8052987 (Litigated)
Maintenance Fee Reminder Mailed 17 Dec, 2018 US7932241
Recordation of Patent Grant Mailed 08 Nov, 2011 US8052987 (Litigated)
Patent Issue Date Used in PTA Calculation 08 Nov, 2011 US8052987 (Litigated)
Issue Notification Mailed 19 Oct, 2011 US8052987 (Litigated)
Dispatch to FDC 03 Oct, 2011 US8052987 (Litigated)
Application Is Considered Ready for Issue 15 Sep, 2011 US8052987 (Litigated)
Issue Fee Payment Verified 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

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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
Patent litigations
EP05012711A Jun, 2013 Taylor Wessing LLP Revoked
EP05012711A Jun, 2013 Sanovel IIaƧ 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

Reclast has patent protection in a total of 36 countries. It's US patent count contributes only to 8.2% of its total global patent coverage. 23 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 Reclast.

Family Patents

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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 Generics:

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

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
Zometa


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