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Celgene Company Profile
What is the competitive landscape for CELGENE, and what generic alternatives to CELGENE drugs are available?
CELGENE has seven approved drugs.
There are forty-nine US patents protecting CELGENE drugs.
There are six hundred and fifty-five patent family members on CELGENE drugs in fifty-one countries and twenty supplementary protection certificates in twelve countries.
Summary for Celgene
| International Patents: | 655 |
| US Patents: | 49 |
| Tradenames: | 7 |
| Ingredients: | 7 |
| NDAs: | 7 |
| Patent Litigation for Celgene: | See patent lawsuits for Celgene |
| PTAB Cases with Celgene as patent owner: | See PTAB cases with Celgene as patent owner |
Drugs and US Patents for Celgene
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | |||||
| Celgene Corp | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | |||||
| Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-005 | Dec 21, 2011 | RX | Yes | No | 7,855,217 | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-003 | Jun 29, 2006 | RX | Yes | No | 5,635,517 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-005 | Dec 21, 2011 | RX | Yes | No | 7,189,740 | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for Celgene
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | 7,723,361 | ➤ Sign Up |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | 6,235,756 | ➤ Sign Up |
| Celgene | REVLIMID | lenalidomide | CAPSULE;ORAL | 021880-001 | Dec 27, 2005 | 8,288,415 | ➤ Sign Up |
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | 6,476,052 | ➤ Sign Up |
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | 6,476,052 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for CELGENE drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 1 mg, 2 mg, 3 mg and 4 mg | ➤ Subscribe | 2017-02-08 |
| ➤ Subscribe | Capsules | 5 mg, 10 mg and 15 mg | ➤ Subscribe | 2010-08-30 |
| ➤ Subscribe | Capsules | 50 mg and 100 mg | ➤ Subscribe | 2006-12-18 |
| ➤ Subscribe | Capsules | 150 mg | ➤ Subscribe | 2014-02-03 |
| ➤ Subscribe | Tablets | 10 mg, 20 mg and30 mg | ➤ Subscribe | 2018-03-22 |
| ➤ Subscribe | Capsules | 25 mg | ➤ Subscribe | 2010-07-12 |
| ➤ Subscribe | Capsules | 2.5 mg and 20 mg | ➤ Subscribe | 2016-07-12 |
| ➤ Subscribe | Capsules | 200 mg | ➤ Subscribe | 2006-09-25 |
| ➤ Subscribe | Injection | 10 mg/vial | ➤ Subscribe | 2013-11-05 |
Non-Orange Book US Patents for Celgene
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 |
|---|---|---|
| 9,433,606 | Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof | ➤ Sign Up |
| 7,629,360 | Methods for the treatment of cachexia and graft v. host disease | ➤ Sign Up |
| 6,011,050 | Substituted phenethylsulfones and method of reducing TNF.alpha. levels | ➤ Sign Up |
| 7,041,680 | (R) and (S) isomers of substituted 2-(2,6-dioxopiperidin-3-yl) phthalimides and 1-oxoisoindolines and methods of using the same | ➤ Sign Up |
| 8,440,194 | Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Celgene Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2177517 | ➤ Sign Up |
| Canada | 2486141 | ➤ Sign Up |
| Spain | 2376879 | ➤ Sign Up |
| Cyprus | 1113929 | ➤ Sign Up |
| Mexico | 346261 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Celgene Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2015 00006 | Denmark | ➤ Sign Up | PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805 |
| 2015000013 | Germany | ➤ Sign Up | PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805 |
| 0150005 00140 | Estonia | ➤ Sign Up | PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013 |
| 90004-6 | Sweden | ➤ Sign Up | PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808 |
| 642 | Luxembourg | ➤ Sign Up | PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.
