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THALOMID Drug Profile
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This drug has seventy patent family members in twenty countries.
The generic ingredient in THALOMID is thalidomide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.
Summary for Tradename: THALOMID
| Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Drug Prices: : | see details |
Pharmacology for Tradename: THALOMID
| Physiological Effect | Decreased Immunologically Active Molecule Activity |
Clinical Trials for: THALOMID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | RX | No | 7,141,018 | Oct 23, 2020 | ||||||||||||||||||||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | RX | No | 6,755,784 | Oct 23, 2020 | ||||||||||||||||||||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | RX | No | 7,230,012 | Dec 9, 2023 | Y | |||||||||||||||||||
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Expired Patents for Tradename: THALOMID
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | 8,143,283 | <disabled> | ||||||||||||||||||||||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | 5,629,327 | <disabled> | ||||||||||||||||||||||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | 8,143,283 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: THALOMID
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| thalidomide | Capsules | 150 mg | Thalomid | 2/3/2014 |
| thalidomide | Capsules | 50 mg and 100 mg | Thalomid | 12/18/2006 |
| thalidomide | Capsules | 200 mg | Thalomid | 9/25/2006 |
Non-Orange Book Patents for Tradename: THALOMID
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,767,326 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug | <disabled in preview> | |||||||||||||||||||||||||||
| 9,006,267 | Pharmaceutical compositions and dosage forms of thalidomide | <disabled in preview> | |||||||||||||||||||||||||||
| 8,039,488 | Methods and compositions for inhibition of angiogenesis | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: THALOMID
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 1586322 | <disabled in preview> | |||||||||||||||||||||||||||
| Australia | 2319102 | <disabled in preview> | |||||||||||||||||||||||||||
| Slovenia | 1562556 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: THALOMID
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB08/039 | United Kingdom | <disabled> | PRODUCT NAME: THALIDOMIDE (INTERNATIONAL NON-PROPRIETARY NAME) 2-(2,6-DIOXOPIPERIDIN-3-YL) ISOINDOLINE-1,3-DIONE (SYSTEMATIC (IUPAC) NAME); REGISTERED: UK EU/1/08/443/001 20080416 | ||||||||||||||||||||||||||
| C0036 | France | <disabled> | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 | ||||||||||||||||||||||||||
| C0036 | France | <disabled> | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 | ||||||||||||||||||||||||||
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How are People Using DrugPatentWatch?
To study exclusivity periods for a number of drugs
— Pharmaceutical company, Canada
To gain knowledge of expiry of patents in anticipation of generic/biosimilars entering the market
— Clinical pharmacist, state drug formulary committee, USA
To identify pharmaceutical product patents and process patents, and drug patent expiries
— Global pharmaceutical regulatory affairs, India
To be able to inform my clients with Part D prescription plans when a brand name drug is going off patent
— Pharmacist, USA
To know the expiration dates of several pharmaceuticals products
— Pharmaceutical company, Spain
To obtain a list of all currently off-patent approved small molecule therapeutics or those that will come off patent in the next 5 years
— Licensing / business development, Saudi Arabia
To have more information regarding the patents and generic products available
— Project manager, bioequivalence studies, Brazil
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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