APOKYN Drug Patent Profile
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Which patents cover Apokyn, and when can generic versions of Apokyn launch?
Apokyn is a drug marketed by Mdd Us and is included in one NDA.
The generic ingredient in APOKYN is apomorphine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Apokyn
A generic version of APOKYN was approved as apomorphine hydrochloride by SAGE CHEMS on February 23rd, 2022.
Summary for APOKYN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 28 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,723 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in APOKYN? | APOKYN excipients list |
| DailyMed Link: | APOKYN at DailyMed |
Recent Clinical Trials for APOKYN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sunovion | Phase 2 |
| ClinData Services, Inc. | Phase 4 |
| Cape Cod Clinical Research Inc. | Phase 4 |
Pharmacology for APOKYN
| Drug Class | Dopaminergic Agonist |
| Mechanism of Action | Dopamine Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for APOKYN
US Patents and Regulatory Information for APOKYN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mdd Us | APOKYN | apomorphine hydrochloride | INJECTABLE;SUBCUTANEOUS | 021264-001 | Apr 20, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mdd Us | APOKYN | apomorphine hydrochloride | INJECTABLE;SUBCUTANEOUS | 021264-002 | Apr 20, 2004 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
