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Details for New Drug Application (NDA): 020785
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NDA 020785 describes THALOMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and three Paragraph IV challenges. Additional details are available on the THALOMID profile page.
The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.
The generic ingredient in THALOMID is thalidomide. There are eleven 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 020785
| Tradename: | THALOMID |
| Applicant: | Celgene |
| Ingredient: | thalidomide |
| Patents: | 9 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 020785
Generic Entry Date for 020785*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 020785
| Physiological Effect | Decreased Immunologically Active Molecule Activity |
Medical Subject Heading (MeSH) Categories for 020785
Suppliers and Packaging for NDA: 020785
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THALOMID | thalidomide | CAPSULE;ORAL | 020785 | NDA | Celgene Corporation | 59572-205 | 59572-205-94 | 10 BLISTER PACK in 1 BOX (59572-205-94) > 28 CAPSULE in 1 BLISTER PACK (59572-205-14) |
| THALOMID | thalidomide | CAPSULE;ORAL | 020785 | NDA | Celgene Corporation | 59572-205 | 59572-205-97 | 10 BLISTER PACK in 1 BOX (59572-205-97) > 1 CAPSULE in 1 BLISTER PACK (59572-205-17) |
Paragraph IV (Patent) Challenges for 020785
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2014-02-03 |
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2006-12-18 |
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2006-09-25 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 16, 1998 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 23, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 23, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 23, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.) | ||||||||
Expired US Patents for NDA 020785
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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