Etidronate disodium - Generic Drug Details
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What are the generic drug sources for etidronate disodium and what is the scope of freedom to operate?
Etidronate disodium
is the generic ingredient in two branded drugs marketed by Mgi Pharma Inc, Apil, and Norvium Bioscience, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for etidronate disodium.
Summary for etidronate disodium
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 1 |
| Patent Applications: | 333 |
| Drug Prices: | Drug price trends for etidronate disodium |
| DailyMed Link: | etidronate disodium at DailyMed |
Recent Clinical Trials for etidronate disodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| UMC Utrecht | Phase 2 |
| Netherlands Brain Foundation | Phase 2 |
US Patents and Regulatory Information for etidronate disodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mgi Pharma Inc | DIDRONEL | etidronate disodium | INJECTABLE;INJECTION | 019545-001 | Apr 20, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | ETIDRONATE DISODIUM | etidronate disodium | TABLET;ORAL | 075800-002 | Jan 24, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | ETIDRONATE DISODIUM | etidronate disodium | TABLET;ORAL | 075800-001 | Jan 24, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 etidronate disodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Mgi Pharma Inc | DIDRONEL | etidronate disodium | INJECTABLE;INJECTION | 019545-001 | Apr 20, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Mgi Pharma Inc | DIDRONEL | etidronate disodium | INJECTABLE;INJECTION | 019545-001 | Apr 20, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
