Dalteparin sodium - Generic Drug Details
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What are the generic sources for dalteparin sodium and what is the scope of freedom to operate?
Dalteparin sodium
is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for dalteparin sodium. One supplier is listed for this compound.
Summary for dalteparin sodium
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 17 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in dalteparin sodium? | dalteparin sodium excipients list |
DailyMed Link: | dalteparin sodium at DailyMed |
Recent Clinical Trials for dalteparin sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Imperial College London | Phase 4 |
Xijing Hospital | Phase 2/Phase 3 |
PharmaDiall Ltd. | Phase 2 |
Pharmacology for dalteparin sodium
Drug Class | Anti-coagulant Low Molecular Weight Heparin |
Medical Subject Heading (MeSH) Categories for dalteparin sodium
Anatomical Therapeutic Chemical (ATC) Classes for dalteparin sodium
US Patents and Regulatory Information for dalteparin sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-002 | May 1, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-001 | Dec 22, 1994 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-011 | May 1, 2007 | RX | Yes | No | ⤷ Sign Up | ⤷ 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 dalteparin sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-001 | Dec 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-004 | Jan 30, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-003 | Mar 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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