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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021217

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NDA 021217 describes EXALGO, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from one supplier. Additional details are available on the EXALGO profile page.

The generic ingredient in EXALGO is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 021217
Tradename:EXALGO
Applicant:Specgx Llc
Ingredient:hydromorphone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021217
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 021217
Suppliers and Packaging for NDA: 021217
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217 NDA AUTHORIZED GENERIC SpecGx LLC 0406-3308 0406-3308-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3308-01)
EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217 NDA AUTHORIZED GENERIC SpecGx LLC 0406-3312 0406-3312-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3312-01)
Paragraph IV (Patent) Challenges for 021217
Tradename Dosage Ingredient NDA Submissiondate
EXALGO TABLET, EXTENDED RELEASE;ORAL hydromorphone hydrochloride 021217 2010-09-02
EXALGO TABLET, EXTENDED RELEASE;ORAL hydromorphone hydrochloride 021217 2010-08-02

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Mar 1, 2010TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:Mar 1, 2010TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:Mar 1, 2010TE:RLD:Yes

Expired US Patents for NDA 021217

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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