Thalomid Patent Expiration

Thalomid is a drug owned by Bristol-myers Squibb Co. It is protected by 20 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 09, 2023. Details of Thalomid'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).
US7230012 Pharmaceutical compositions and dosage forms of thalidomide
Dec, 2023

(1 year, 5 days ago)

Expired
US6561977 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Oct, 2020

(4 years ago)

Expired
US6869399 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Oct, 2020

(4 years ago)

Expired
US8626531 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Oct, 2020

(4 years ago)

Expired
US7959566 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Oct, 2020

(4 years ago)

Expired
US7141018 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Oct, 2020

(4 years ago)

Expired
US6315720 Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
Oct, 2020

(4 years ago)

Expired
US8315886 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Oct, 2020

(4 years ago)

Expired
US6755784 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
Oct, 2020

(4 years ago)

Expired
US7874984 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Aug, 2018

(6 years ago)

Expired
US8589188 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Aug, 2018

(6 years ago)

Expired
US6561976 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Aug, 2018

(6 years ago)

Expired
US6908432 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Aug, 2018

(6 years ago)

Expired
US6045501 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Aug, 2018

(6 years ago)

Expired
US8204763 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Aug, 2018

(6 years ago)

Expired
US7435745 Methods and compositions for inhibition of angiogenesis
Nov, 2017

(7 years ago)

Expired
US5629327 Methods and compositions for inhibition of angiogenesis
May, 2014

(10 years ago)

Expired
US8143283 Methods for treating blood-born tumors with thalidomide
Mar, 2013

(11 years ago)

Expired
US6235756 Methods and compositions for inhibition of angiogenesis by thalidomide
Mar, 2013

(11 years ago)

Expired
US7723361 Methods for inhibiting undesired angiogenesis in patients having tumors with thalidomide
Mar, 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 Thalomid's patents.

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

Activity Date Patent Number
Patent litigations
Expire Patent 17 Jul, 2023 US7959566
Expire Patent 27 Feb, 2023 US7874984
Maintenance Fee Reminder Mailed 30 Jan, 2023 US7959566
Maintenance Fee Reminder Mailed 12 Sep, 2022 US7874984
Expire Patent 16 Nov, 2020 US7435745 (Litigated)
Maintenance Fee Reminder Mailed 01 Jun, 2020 US7435745 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 14 Dec, 2018 US7959566
Payment of Maintenance Fee, 12th Year, Large Entity 12 Dec, 2018 US7230012 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 25 Jul, 2018 US7874984
Payment of Maintenance Fee, 12th Year, Large Entity 29 May, 2018 US7141018


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Thalomid and ongoing litigations to help you estimate the early arrival of Thalomid generic.

Thalomid's Litigations

Thalomid been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 23, 2015, against patent number US6315720. The petitioner Coalition for Affordable Drugs VI LLC, challenged the validity of this patent, with Celgene Corporation as the respondent. Click below to track the latest information on how companies are challenging Thalomid's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6045501 April, 2015 Final Written Decision
(26 Oct, 2016)
Celgene Corporation Coalition For Affordable Drugs VI LLC
US6315720 April, 2015 FWD Entered
(26 Oct, 2016)
Celgene Corporation Coalition for Affordable Drugs VI LLC


FDA has granted some exclusivities to Thalomid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Thalomid, 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 Thalomid.

Exclusivity Information

Thalomid holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Thalomid's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE) May 25, 2013

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Thalomid 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 Thalomid's family patents as well as insights into ongoing legal events on those patents.

Thalomid's Family Patents

Thalomid has patent protection in a total of 19 countries. It's US patent count contributes only to 17.9% of its total global patent coverage. 4 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 Thalomid.

Family Patents

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Generic Launch

Generic Release Date:

Thalomid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 09, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Thalomid Generic API suppliers:

Thalidomide is the generic name for the brand Thalomid. 1 company has already filed for the generic of Thalomid. Check out the entire list of companies who have already received approval for Thalomid's generic

How can I launch a generic of Thalomid before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Thalomid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Thalomid'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 Thalomid -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
50 mg and 100 mg 18 Dec, 2006 1 23 Oct, 2020 Extinguished
200 mg 25 Sep, 2006 1 23 Oct, 2020 Extinguished
150 mg 03 Feb, 2014 1 09 Dec, 2023

Alternative Brands for Thalomid

Thalomid which is used for treating multiple myeloma and erythema nodosum leprosum., has several other brand drugs in the same treatment category . 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
Bristol Myers Squibb
Revlimid used for treating mantle cell lymphoma, multiple myeloma, and myelodysplastic syndromes.





About Thalomid

Thalomid is a drug owned by Bristol-Myers Squibb Co. It is used for treating multiple myeloma and erythema nodosum leprosum. Thalomid uses Thalidomide as an active ingredient. Thalomid was launched by Bristol-Myers in 1998.

Approval Date:

Thalomid was approved by FDA for market use on 16 July, 1998.

Active Ingredient:

Thalomid uses Thalidomide as the active ingredient. Check out other Drugs and Companies using Thalidomide ingredient

Treatment:

Thalomid is used for treating multiple myeloma and erythema nodosum leprosum.

Dosage:

Thalomid is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG CAPSULE Prescription ORAL
50MG CAPSULE Prescription ORAL
100MG CAPSULE Prescription ORAL
150MG CAPSULE Prescription ORAL