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Generated: July 23, 2017
What is the competitive landscape for CELGENE, and what generic alternatives to CELGENE drugs are available?
CELGENE has six approved drugs.| Patents: | 51 |
| Tradenames: | 6 |
| Ingredients: | 6 |
| NDAs: | 6 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | 6,869,399 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-003 | Jun 29, 2006 | RX | Yes | No | 6,281,230 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | 7,874,984 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-002 | Dec 27, 2005 | RX | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-001 | Dec 27, 2005 | RX | Yes | No | 5,635,517 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | 5,635,517 | ► Subscribe | ||||||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | 6,316,471 | ► Subscribe | ||||||||||||||||||||||
Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-003 | Jun 29, 2006 | 6,281,230 | ► Subscribe | ||||||||||||||||||||||
Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-001 | Dec 27, 2005 | 6,555,554 | ► Subscribe | ||||||||||||||||||||||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | 7,723,361 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
pomalidomide | Capsules | 1 mg, 2 mg, 3 mg and 4 mg | POMALYST | 2/8/2017 |
thalidomide | Capsules | 150 mg | THALOMID | 2/3/2014 |
romidepsin | Injection | 10 mg/vial | ISTODAX | 11/5/2013 |
lenalidomide | Capsules | 5 mg, 10 mg and 15 mg | REVLIMID | 8/30/2010 |
lenalidomide | Capsules | 25 mg | REVLIMID | 7/12/2010 |
thalidomide | Capsules | 50 mg and 100 mg | THALOMID | 12/18/2006 |
thalidomide | Capsules | 200 mg | THALOMID | 9/25/2006 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,863,297 | Methods of using 4-(amino)-2-(2,6-dioxo(3-piperidly))-isoindoline-3-dione for the treatment of myelodysplastic syndromes | ► Subscribe | |||||||||||||||||||||||||||
| 8,093,283 | Solid forms comprising (+)-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisi- noline-1,3-dione, compositions thereof, and uses thereof | ► Subscribe | |||||||||||||||||||||||||||
| 7,459,466 | Substituted 2-(2,6-dioxopiperidin-3-yl)-phthalimides and -1-oxoisoindolines and method of reducing TNF.alpha. levels | ► Subscribe | |||||||||||||||||||||||||||
| 8,722,647 | Methods for treating amyloidosis using 4-(amino)-2-(2,6-Dioxo(3-piperidyl))- isoindoline-1,3-dione | ► Subscribe | |||||||||||||||||||||||||||
| 7,629,360 | Methods for the treatment of cachexia and graft v. host disease | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 2046331 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1083064 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 2426118 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2352629 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20100664 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0150005 00140 | Estonia | ► Subscribe | PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013 | ||||||||||||||||||||||||||
| 140 | Estonia | ► Subscribe | |||||||||||||||||||||||||||
| 0925294/01 | Switzerland | ► Subscribe | PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007 | ||||||||||||||||||||||||||
| C/GB07/047 | United Kingdom | ► Subscribe | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/047 GRANTED TO CELGENE CORPORATION IN RESPECT OF THE PRODUCT LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6228 DATED 01 OCTOBER 2008, AND THE CORRECTION OF WHICH WAS ADVERTISED IN JOURNAL NO 6523 DATED 28 MAY 2014, HAS HAD ITS MAXIMUM PERIOD OF DURATION FURTHER CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 18 JUNE 2022. | ||||||||||||||||||||||||||
| C033/2007 | Ireland | ► Subscribe | SPC033/2007: 20080507, EXPIRES: 20220613 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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