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Last Updated: April 29, 2024

Apomorphine hydrochloride - Generic Drug Details

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What are the generic drug sources for apomorphine hydrochloride and what is the scope of freedom to operate?

Apomorphine hydrochloride is the generic ingredient in three branded drugs marketed by Sumitomo Pharma Am, Mdd Us, and Sage Chems, and is included in three NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apomorphine hydrochloride has two hundred and fifty-four patent family members in twenty-six countries.

There are three drug master file entries for apomorphine hydrochloride. Two suppliers are listed for this compound.

Summary for apomorphine hydrochloride

International Patents:	254
US Patents:	14
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	47
Patent Applications:	5,686
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apomorphine hydrochloride
What excipients (inactive ingredients) are in apomorphine hydrochloride?	apomorphine hydrochloride excipients list
DailyMed Link:	apomorphine hydrochloride at DailyMed

Recent Clinical Trials for apomorphine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
William Ondo, MD	Phase 4
Sunovion	Phase 4
Rennes University Hospital	Phase 4

See all apomorphine hydrochloride clinical trials

Pharmacology for apomorphine hydrochloride

Drug Class	Dopaminergic Agonist
Mechanism of Action	Dopamine Agonists

Medical Subject Heading (MeSH) Categories for apomorphine hydrochloride

Dopamine Agonists
Emetics

Anatomical Therapeutic Chemical (ATC) Classes for apomorphine hydrochloride

US Patents and Regulatory Information for apomorphine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020		DISCN	Yes	No	⤷ 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

Expired US Patents for apomorphine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020	⤷ Try a Trial	⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020	⤷ Try a Trial	⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020	⤷ Try a Trial	⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020	⤷ Try a Trial	⤷ Try a Trial
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for apomorphine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
South Korea	20190103472	설하 아포모르핀 (Sublingual Apomorphine)	⤷ Try a Trial
Brazil	PI0410956	pelìculas com base em óxido de polietileno e sistemas de liberação de droga feitos delas	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007067494		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	03012531		⤷ Try a Trial
Japan	2008515403		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.