DEXTROMETHORPHAN POLISTIREX - Generic Drug Details

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

Dextromethorphan polistirex is the generic ingredient in two branded drugs marketed by Rb Hlth, Amneal, and Tris Pharma Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for dextromethorphan polistirex. Twenty-eight suppliers are listed for this compound.

Summary for DEXTROMETHORPHAN POLISTIREX

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	1,952
What excipients (inactive ingredients) are in DEXTROMETHORPHAN POLISTIREX?	DEXTROMETHORPHAN POLISTIREX excipients list
DailyMed Link:	DEXTROMETHORPHAN POLISTIREX at DailyMed

Pharmacology for DEXTROMETHORPHAN POLISTIREX

Drug Class	Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for DEXTROMETHORPHAN POLISTIREX

Antitussive Agents
Excitatory Amino Acid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DEXTROMETHORPHAN POLISTIREX

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN POLISTIREX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DELSYM	Extended-release Suspension	dextromethorphan polistirex	30 mg/5 mL	018658	1	2009-01-12

US Patents and Regulatory Information for DEXTROMETHORPHAN POLISTIREX

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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
Rb Hlth	DELSYM	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	018658-001	Oct 8, 1982		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tris Pharma Inc	DEXTROMETHORPHAN POLISTIREX	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091135-001	May 25, 2012		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	DEXTROMETHORPHAN POLISTIREX	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	203133-001	Jul 28, 2017		OTC	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

Expired US Patents for DEXTROMETHORPHAN POLISTIREX

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	DELSYM	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	018658-001	Oct 8, 1982	⤷ Sign Up	⤷ Sign Up
Rb Hlth	DELSYM	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	018658-001	Oct 8, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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