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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Citi
Moodys
Johnson and Johnson
Cantor Fitzgerald
Express Scripts
Teva
Accenture
Fuji

Generated: July 21, 2018

DrugPatentWatch Database Preview

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 patent protection?

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-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Hydrocodone bitartrate has seven hundred and thirty-seven patent family members in fifty-one countries.

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
➤ Sign Up➤ Sign Up10MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up40MGCAPSULE, 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
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX 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

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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 206627-001 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for hydrocodone bitartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,421,201 Treating pain in patients with hepatic impairment ➤ Sign Up
9,522,147 Treating pain in patients with hepatic impairment ➤ Sign Up
6,730,325 Multiparticulate modified release composition ➤ Sign Up
6,793,936 Multiparticulate modified release composition ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fuji
Chinese Patent Office
Daiichi Sankyo
Boehringer Ingelheim
Mallinckrodt
Moodys
Julphar
Citi

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.