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Last Updated: November 22, 2024

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX - Generic Drug Details


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What are the generic sources for chlorpheniramine polistirex; hydrocodone polistirex and what is the scope of freedom to operate?

Chlorpheniramine polistirex; hydrocodone polistirex is the generic ingredient in four branded drugs marketed by Ecr Pharma, Tris Pharma Inc, Neos Theraps Inc, and Ucb Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Recent Clinical Trials for CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

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

SponsorPhase
MallinckrodtPhase 1

See all CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX clinical trials

Pharmacology for CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Paragraph IV (Patent) Challenges for CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TUSSIONEX PENNKINETIC Extended-release Capsules chlorpheniramine polistirex; hydrocodone polistirex 8 mg/10 mg and 4 mg/5 mg 019111 1 2004-09-10

US Patents and Regulatory Information for CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Neos Theraps Inc HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 091671-001 Jun 29, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ecr Pharma TUSSICAPS chlorpheniramine polistirex; hydrocodone polistirex CAPSULE, EXTENDED RELEASE;ORAL 077273-001 Sep 24, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tris Pharma Inc HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 091632-001 Oct 1, 2010 RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ecr Pharma TUSSICAPS chlorpheniramine polistirex; hydrocodone polistirex CAPSULE, EXTENDED RELEASE;ORAL 077273-002 Sep 24, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ucb Inc TUSSIONEX PENNKINETIC chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 019111-001 Dec 31, 1987 DISCN Yes 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 CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc TUSSIONEX PENNKINETIC chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 019111-001 Dec 31, 1987 ⤷  Sign Up ⤷  Sign Up
Ucb Inc TUSSIONEX PENNKINETIC chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 019111-001 Dec 31, 1987 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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