DrugPatentWatch Database Preview
FRAGMIN Drug Profile
When do Fragmin patents expire, and what generic alternatives are available?
Fragmin is a drug marketed by Pfizer Inc and is included in one NDA.
The generic ingredient in FRAGMIN is dalteparin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalteparin sodium profile page.
Summary for FRAGMIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 33 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FRAGMIN |
| DailyMed Link: | FRAGMIN at DailyMed |
Generic Entry Opportunity Date for FRAGMIN
Generic Entry Date for FRAGMIN*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION NDA:
Dosage:
INJECTABLE;SUBCUTANEOUS |
*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.
Recent Clinical Trials for FRAGMIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sunnybrook Research Institute | Phase 3 |
| Sunnybrook Health Sciences Centre | Phase 3 |
| Asan Medical Center | Phase 2 |
Pharmacology for FRAGMIN
| Drug Class | Anti-coagulant Low Molecular Weight Heparin |
US Patents and Regulatory Information for FRAGMIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;INJECTION | 020287-008 | Apr 4, 2002 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-009 | May 1, 2007 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-005 | Apr 4, 2002 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-010 | May 1, 2007 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-001 | Dec 22, 1994 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-003 | Mar 18, 1996 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-004 | Jan 30, 1998 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 FRAGMIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-001 | Dec 22, 1994 | Start Trial | Start Trial |
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-004 | Jan 30, 1998 | Start Trial | Start Trial |
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-003 | Mar 18, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
