HALOPERIDOL DECANOATE - Generic Drug Details
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What are the generic drug sources for haloperidol decanoate and what is the scope of patent protection?
Haloperidol decanoate
is the generic ingredient in two branded drugs marketed by Janssen Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for haloperidol decanoate. Fifteen suppliers are listed for this compound.
Summary for HALOPERIDOL DECANOATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 12 |
NDAs: | 13 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 8 |
Patent Applications: | 339 |
Drug Prices: | Drug price trends for HALOPERIDOL DECANOATE |
What excipients (inactive ingredients) are in HALOPERIDOL DECANOATE? | HALOPERIDOL DECANOATE excipients list |
DailyMed Link: | HALOPERIDOL DECANOATE at DailyMed |
Recent Clinical Trials for HALOPERIDOL DECANOATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Case Western Reserve University | Phase 3 |
National Institutes of Health (NIH) | Phase 3 |
National Institute of Mental Health (NIMH) | Phase 3 |
Pharmacology for HALOPERIDOL DECANOATE
Drug Class | Typical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for HALOPERIDOL DECANOATE
US Patents and Regulatory Information for HALOPERIDOL DECANOATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Meitheal | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 214507-002 | Jul 26, 2021 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Labs Ltd | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 075440-002 | Feb 28, 2000 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 211180-001 | Oct 22, 2019 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hospira | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 075176-001 | Feb 9, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mankind Pharma | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 216730-001 | May 23, 2023 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Meitheal | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 214507-001 | Jul 26, 2021 | AO | RX | No | 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 |
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