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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
QuintilesIMS
Fish and Richardson
Mallinckrodt
Medtronic
Julphar
Queensland Health
Accenture
Federal Trade Commission

Generated: September 24, 2018

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Hydrocodone bitartrate - Generic Drug Details

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

Hydrocodone bitartrate is the generic ingredient in nine branded drugs marketed by Pernix Ireland Pain, Purdue Pharma Lp, Teva Branded Pharm, Actavis Labs Fl Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, Vintage Pharms, Abbvie, Alpharma Us Pharms, Mayne Pharma Inc, Paddock Llc, Tris Pharma Inc, and Cypress Pharm, and is included in seventeen NDAs. There are fifty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for hydrocodone bitartrate. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for hydrocodone bitartrate
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for hydrocodone bitartrate
Synonyms for hydrocodone bitartrate
.codon
(1S,5R,13R,17R)-10-METHOXY-4-METHYL-12-OXA-4-AZAPENTACYCLO[9.6.1.0(1),(1)(3).0?,(1)?.0?,(1)?]OCTADECA-7(18),8,10-TRIEN-14-ONE; (2R,3R)-2,3-DIHYDROXYBUTANEDIOIC ACID
143-71-5
4,5-Epoxy-3-methoxy-17-methyl-5|A-morphinan-6-one (2R,3R)-2,3-dihydroxybutanedioate (1:1)
4,5-Epoxy-3-methoxy-17-methyl-5alpha-morphinan-6-one (2R,3R)-2,3-dihydroxybutanedioate (1:1)
9GU1G05Y03
AN-23265
API0002943
Biocodone
Brocodid longum
C18H21NO3.C4H6O6
CHEMBL2062267
Codone
Dicodethal
Dicodrine
Dicotrate
Dihydrocodeinone acid tartrate
Dihydrocodeinone bitartrate
Dihydrocodeinone hydrogen tartrate
Dihydrocodeinone tartrate
DTXSID40162277
EINECS 205-608-1
heta)]-2,3-dihydroxybutanedioate(1:1)
Hycon
Hydrocodone (+)-bitartrate salt
Hydrocodone Bitartrate (anhydrous)
hydrocodone bitartrate methanol*solution
hydrocodone bitartrate salt
hydrocodone bitartrate--dea schedule*ii item
Hydrocodone hydrogen tartrate
Hydrokon
Hysingla
LS-92160
MFCD00078557
Morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl-, tartrate (1:1)
Morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5?)-, [R-(R,R)]-2,3-dihydroxybutanedioate (1:1)
Morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5alpha)-, (2R,3R)-2,3-dihydroxybutanedioate (1:1)
Morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5alpha)-, (R-(R*,R*))-2,3-dihydroxybutanedioate (1:1)
Morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5alpha)-, (theta-(theta,theta))-2,3-dihydroxybutanedioate (1:1)
Morphinan-6-one, 4,5alpha-epoxy-3-methoxy-17-methyl-, tartrate(1:1)
morphinan-6-one,4,5-epoxy-3-methoxy-17-methyl-,(5alpha)-,[theta-(theta,t
OJHZNMVJJKMFGX-RNWHKREASA-N
PL002535
Robidone
SCHEMBL154972
Stodcodon
Synkonin
UNII-9GU1G05Y03
Tentative approvals for HYDROCODONE BITARTRATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial40MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial10MGCAPSULE, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for hydrocodone bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Teva Branded Pharm VANTRELA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 207975-003 Jan 17, 2017 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for hydrocodone bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
QuintilesIMS
Fish and Richardson
Mallinckrodt
Medtronic
Julphar
Queensland Health
Accenture
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.