Apomorphine hydrochloride - Generic Drug Details

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What are the generic drug sources for apomorphine hydrochloride and what is the scope of patent protection?

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

Apomorphine hydrochloride has two hundred and forty-nine patent family members in twenty-five countries.

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

Summary for apomorphine hydrochloride

International Patents:	249
US Patents:	19
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	47
Patent Applications:	5,638
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

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
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020	See Plans and Pricing	See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020	See Plans and Pricing	See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020	See Plans and Pricing	See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020	See Plans and Pricing	See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	See Plans and Pricing	See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	See Plans and Pricing	See Plans and Pricing
Sunovion Pharms Inc	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020	See Plans and Pricing	See Plans and Pricing
>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
China	101316579	Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions	See Plans and Pricing
European Patent Office	3735988	FILMS SUBLINGUES (SUBLINGUAL FILMS)	See Plans and Pricing
Mexico	2013006911	PELICULAS SUB-LINGUALES. (SUBLINGUAL FILMS.)	See Plans and Pricing
Canada	2456234	INSTRUMENTS OPTIQUES ACCORDABLES (TUNABLE OPTICAL INSTRUMENTS)	See Plans and Pricing
Austria	536868		See Plans and Pricing
Canada	2544776	FILMS A BASE D'OXYDE DE POLYETHYLENE ET SYSTEMES D'ADMINISTRATION DE MEDICAMENTS EN ETANT FAITS (POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY SYSTEMS MADE THEREFROM)	See Plans and Pricing
Canada	2821756	FILMS SUBLINGUAUX (SUBLINGUAL FILMS)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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