HALOPERIDOL DECANOATE Drug Patent Profile
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Which patents cover Haloperidol Decanoate, and what generic alternatives are available?
Haloperidol Decanoate is a drug marketed by 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 twelve NDAs.
The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Haloperidol Decanoate
A generic version of HALOPERIDOL DECANOATE was approved as haloperidol decanoate by FRESENIUS KABI USA on December 19th, 1997.
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Questions you can ask:
- What is the 5 year forecast for HALOPERIDOL DECANOATE?
- What are the global sales for HALOPERIDOL DECANOATE?
- What is Average Wholesale Price for HALOPERIDOL DECANOATE?
Summary for HALOPERIDOL DECANOATE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 8 |
| Patent Applications: | 225 |
| Drug Prices: | Drug price information for HALOPERIDOL DECANOATE |
| What excipients (inactive ingredients) are in HALOPERIDOL DECANOATE? | HALOPERIDOL DECANOATE excipients list |
| DailyMed Link: | HALOPERIDOL DECANOATE at DailyMed |
See drug prices for HALOPERIDOL DECANOATE
Recent Clinical Trials for HALOPERIDOL DECANOATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Mental Health (NIMH) | Phase 3 |
| Case Western Reserve University | Phase 3 |
| National Institutes of Health (NIH) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 074893-001 | Dec 19, 1997 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Somerset Theraps Llc | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 209101-002 | Jul 3, 2018 | 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 | ||||
| Gland Pharma Ltd | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 205241-002 | May 12, 2017 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 214507-002 | 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 |
