DALTEPARIN SODIUM - Generic Drug Details
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What are the generic sources for dalteparin sodium and what is the scope of patent protection?
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 |
| 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 | 020287-010 | May 1, 2007 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-006 | Apr 4, 2002 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-009 | May 1, 2007 | RX | Yes | 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 | 020287-004 | Jan 30, 1998 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-012 | Mar 15, 2022 | 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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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 verification 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.
ISSN: 2162-2639
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