Cocaine hydrochloride - Generic Drug Details
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What are the generic drug sources for cocaine hydrochloride and what is the scope of freedom to operate?
Cocaine hydrochloride
is the generic ingredient in two branded drugs marketed by Noden Pharma and Omnivium Pharms, and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for cocaine hydrochloride. Three suppliers are listed for this compound.
Summary for cocaine hydrochloride
| US Patents: | 12 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 35 |
| Clinical Trials: | 483 |
| Patent Applications: | 823 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cocaine hydrochloride |
| What excipients (inactive ingredients) are in cocaine hydrochloride? | cocaine hydrochloride excipients list |
| DailyMed Link: | cocaine hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cocaine hydrochloride
*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 cocaine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Los Angeles | Early Phase 1 |
| Multidisciplinary Association for Psychedelic Studies | Early Phase 1 |
| Spaulding Rehabilitation Hospital | Early Phase 1 |
Medical Subject Heading (MeSH) Categories for cocaine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for cocaine hydrochloride
US Patents and Regulatory Information for cocaine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Omnivium Pharms | NUMBRINO | cocaine hydrochloride | SOLUTION;NASAL | 209575-001 | Jan 10, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ 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 |
