Hydrocodone bitartrate - Generic Drug Details
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What are the generic drug sources for hydrocodone bitartrate and what is the scope of patent protection?
Hydrocodone bitartrate
is the generic ingredient in eleven branded drugs marketed by Alvogen, Recro Gainesville, Purdue Pharma Lp, Teva Branded Pharm, Nostrum Labs Inc, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, Abbvie, Alpharma Us Pharms, Apozeal Pharms, Mayne Pharma Inc, Padagis Us, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are thirty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Hydrocodone bitartrate has three hundred and eighty-two patent family members in forty-nine countries.
There are sixteen drug master file entries for hydrocodone bitartrate. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for hydrocodone bitartrate
International Patents: | 382 |
US Patents: | 39 |
Tradenames: | 11 |
Applicants: | 18 |
NDAs: | 19 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 23 |
Clinical Trials: | 30 |
Patent Applications: | 457 |
Drug Prices: | Drug price trends for hydrocodone bitartrate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for hydrocodone bitartrate |
What excipients (inactive ingredients) are in hydrocodone bitartrate? | hydrocodone bitartrate excipients list |
DailyMed Link: | hydrocodone bitartrate at DailyMed |
Recent Clinical Trials for hydrocodone bitartrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute on Drug Abuse (NIDA) | Phase 1 |
Elysium Therapeutics, Inc. | Phase 1 |
Medpace, Inc. | Phase 1 |
Generic filers with tentative approvals for HYDROCODONE BITARTRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 40MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG | CAPSULE, 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 Class | Opioid Agonist |
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for hydrocodone bitartrate
Anatomical Therapeutic Chemical (ATC) Classes for hydrocodone bitartrate
Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
HYSINGLA ER | Extended-release Tablets | hydrocodone bitartrate | 30 mg, 40 mg, 80 mg, and 100 mg | 206627 | 1 | 2015-05-08 |
HYSINGLA ER | Extended-release Tablets | hydrocodone bitartrate | 20 mg, 60 mg, and 120 mg | 206627 | 1 | 2015-04-15 |
ZOHYDRO ER | Extended-release Capsules | hydrocodone bitartrate | 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg | 202880 | 1 | 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 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-004 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-005 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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 |
---|---|---|---|---|---|---|---|
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-005 | Nov 20, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-002 | Nov 20, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-006 | Nov 20, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for hydrocodone bitartrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2388615 | ⤷ Sign Up | |
Taiwan | 201300140 | Encased tamper resistant controlled release dosage forms | ⤷ Sign Up |
Hong Kong | 1132189 | TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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