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:	48
Patent Applications:	6,116
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
ISS, Inc.	Phase 2
Alexza Pharmaceuticals, Inc.	Phase 2
DSG	Phase 2

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	210875-001	May 21, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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	210875-002	May 21, 2020	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	⤷ Sign Up	⤷ Sign Up
>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
Canada	2473975	SYSTEMES D'APPORT SOUS FORME DE FILM A BASE DE GLUCANE (GLUCAN BASED FILM DELIVERY SYSTEMS)	⤷ Sign Up
Cyprus	1122988		⤷ Sign Up
South Korea	101946774		⤷ Sign Up
South Korea	20190103472	설하 아포모르핀 (Sublingual Apomorphine)	⤷ Sign Up
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)	⤷ Sign Up
Hong Kong	1193969	舌下薄膜 (SUBLINGUAL FILMS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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