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Serving leading biopharmaceutical companies globally:

McKinsey
Cantor Fitzgerald
Medtronic
Federal Trade Commission
Johnson and Johnson
Cerilliant
McKesson
Teva
US Army
Argus Health

Generated: February 20, 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 twenty-six patent family members in fifty-one countries.

There are twenty-two drug master file entries for hydrocodone bitartrate. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for hydrocodone bitartrate
Pharmacology for hydrocodone bitartrate
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for hydrocodone bitartrate
Tentative approvals for HYDROCODONE BITARTRATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial10MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Try a Free Trial➤ Try a Free Trial40MGCAPSULE, 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 206627-001 Nov 20, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 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 206627-004 Nov 20, 2014 RX 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 206627-005 Nov 20, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurolife Pharma Llc HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 204575-001 Jun 2, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 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 207975-004 Jan 17, 2017 DISCN 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 202880-004 Oct 25, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Ireland Pain ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 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 206627-001 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 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 206627-004 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
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 206627-006 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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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
9,308,170 Pharmaceutical formulation containing gelling agent ➤ Try a Free Trial
9,387,173 Pharmaceutical formulation containing gelling agent ➤ Try a Free Trial
7,144,587 Pharmaceutical formulation containing opioid agonist, opioid antagonist and bittering agent ➤ Try a Free Trial
8,114,383 Abuse-proofed dosage form ➤ Try a Free Trial
8,192,722 Abuse-proof dosage form ➤ Try a Free Trial
9,278,074 Controlled release hydrocodone formulations ➤ Try a Free Trial
8,389,007 Pharmaceutical composition containing gelling agent ➤ Try a Free Trial
9,572,805 Controlled release hydrocodone formulations ➤ Try a Free Trial
9,763,886 Tamper resistant dosage forms ➤ Try a Free Trial
9,861,583 Pharmaceutical formulation containing gelling agent ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for hydrocodone bitartrate

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Queensland Health
Fuji
Daiichi Sankyo
Argus Health
QuintilesIMS
AstraZeneca
Federal Trade Commission
Boehringer Ingelheim

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.

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