Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Dow
Boehringer Ingelheim
Merck
Colorcon

Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Hydrocodone bitartrate - Generic Drug Details

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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

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

Hydrocodone bitartrate has seven hundred and eighty-six patent family members in fifty-two countries.

There are twenty-three drug master file entries for hydrocodone bitartrate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for hydrocodone bitartrate

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

SponsorPhase
Sun Pharma Advanced Research Company LimitedPhase 1
GrĂ¼nenthal GmbHPhase 1
Purdue Pharma LPPhase 2

See all hydrocodone bitartrate clinical trials

Recent Litigation for hydrocodone bitartrate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc.2018-06-07
Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc.2018-01-11
Purdue Pharma L.P. v. Kashiv Pharma, LLC2018-01-03

See all hydrocodone bitartrate litigation

Generic filers with tentative approvals for HYDROCODONE BITARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial10MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial20MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydrocodone bitartrate
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for hydrocodone bitartrate
Synonyms for hydrocodone bitartrate
.codon
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
Hysingla ER
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
Robidone
SCHEMBL154972
Stodcodon
Synkonin
UNII-9GU1G05Y03
Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE
Tradename Dosage Ingredient NDA Submissiondate
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-05-08
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-04-15
ZOHYDRO ER CAPSULE, EXTENDED RELEASE;ORAL hydrocodone bitartrate 202880 2014-02-26

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 ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm VANTRELA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 207975-004 Jan 17, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>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 hydrocodone bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
Medtronic
Express Scripts

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.