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, 10 months 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
(5 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
(5 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
(5 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
(5 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
(5 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
(5 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
(5 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
(5 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
(7 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
(7 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
(7 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
(7 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
(7 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
(7 years ago) |
Expired
|
| US7435745 | Methods and compositions for inhibition of angiogenesis |
Nov, 2017
(8 years ago) |
Expired
|
| US5629327 | Methods and compositions for inhibition of angiogenesis |
May, 2014
(11 years ago) |
Expired
|
| US8143283 | Methods for treating blood-born tumors with thalidomide |
Mar, 2013
(12 years ago) |
Expired
|
| US6235756 | Methods and compositions for inhibition of angiogenesis by thalidomide |
Mar, 2013
(12 years ago) |
Expired
|
| US7723361 | Methods for inhibiting undesired angiogenesis in patients having tumors with thalidomide |
Mar, 2013
(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 Thalomid's patents.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent
Critical | 17 Jul, 2023 | US7959566 |
| Expire Patent
Critical | 27 Feb, 2023 | US7874984 |
| Maintenance Fee Reminder Mailed
Critical | 30 Jan, 2023 | US7959566 |
| Maintenance Fee Reminder Mailed
Critical | 12 Sep, 2022 | US7874984 |
| Expire Patent
Critical | 16 Nov, 2020 | US7435745 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6045501 | April, 2015 |
Final Written Decision
(26 Oct, 2016) | Celgene Corporation | Coalition For Affordable Drugs VI LLC |
| US6315720 | 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 |
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
Explore Our Curated Drug Screens
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 |
| |||
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 2003.
Approval Date:
Thalomid was approved by FDA for market use on 17 January, 2003.
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 |