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Oxybutynin - Generic Drug Details
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What are the generic drug sources for oxybutynin and what is the scope of freedom to operate?
Oxybutynin
is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan, Par Pharm Inc, Ortho Mcneil Janssen, Anda Repository, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Janssen Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma Inc, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Rubicon, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Emcure Pharms Ltd, Eywa, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in forty NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Oxybutynin has one hundred and twenty patent family members in twenty-three countries.
There are sixteen drug master file entries for oxybutynin. One supplier is listed for this compound.
Summary for oxybutynin
International Patents: | 120 |
US Patents: | 13 |
Tradenames: | 8 |
Applicants: | 34 |
NDAs: | 40 |
Drug Master File Entries: | 16 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 70 |
Clinical Trials: | 86 |
Patent Applications: | 4,237 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for oxybutynin |
Drug Sales Revenues: | Drug sales revenues for oxybutynin |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxybutynin |
DailyMed Link: | oxybutynin at DailyMed |
Recent Clinical Trials for oxybutynin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
Alliance for Clinical Trials in Oncology | Phase 2 |
Apnimed | Phase 2 |
Pharmacology for oxybutynin
Drug Class | Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Paragraph IV (Patent) Challenges for OXYBUTYNIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
OXYTROL | FILM, EXTENDED RELEASE;TRANSDERMAL | oxybutynin | 021351 | 2008-08-19 |
US Patents and Regulatory Information for oxybutynin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Quantum Pharmics | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 072296-001 | Dec 8, 1988 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-002 | Dec 16, 1998 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Anda Repository | OXYBUTYNIN CHLORIDE | oxybutynin chloride | SYRUP;ORAL | 075039-001 | Jan 29, 1999 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Teva Pharms Usa | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 071655-001 | Nov 14, 1988 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Novitium Pharma | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 209823-001 | Oct 23, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Amneal Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 204010-002 | Nov 23, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Amneal Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 204010-003 | Nov 23, 2015 | AB | RX | No | No | Start Trial | Start Trial | 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 oxybutynin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | Start Trial | Start Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | Start Trial | Start Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | Start Trial | Start Trial |
Allergan | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | Start Trial | Start Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | Start Trial | Start Trial |
Allergan | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | Start Trial | Start Trial |
Allergan | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxybutynin
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2004041187 | Start Trial |
New Zealand | 546106 | Start Trial |
South Korea | 100856523 | Start Trial |
South Africa | 200602046 | Start Trial |
Germany | 60143477 | Start Trial |
South Africa | 200505985 | Start Trial |
World Intellectual Property Organization (WIPO) | 2004041188 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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