OXYBUTYNIN - Generic Drug Details
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What are the generic sources for oxybutynin and what is the scope of patent protection?
Oxybutynin
is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan, Abbvie, Chartwell Rx, Ortho Mcneil Janssen, Lannett Co Inc, Pharm Assoc, Pharmobedient Cnsltg, Janssen Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Impax Pharms, Norvium Bioscience, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Hibrow Hlthcare, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in forty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for oxybutynin. One supplier is listed for this compound.
Summary for OXYBUTYNIN
US Patents: | 3 |
Tradenames: | 8 |
Applicants: | 34 |
NDAs: | 42 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 98 |
Patent Applications: | 6,618 |
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 |
What excipients (inactive ingredients) are in OXYBUTYNIN? | OXYBUTYNIN excipients list |
DailyMed Link: | OXYBUTYNIN at DailyMed |
Recent Clinical Trials for OXYBUTYNIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Reinier de Graaf Groep | Phase 3 |
Seoul National University Hospital | Phase 2 |
Il-Yang Pharm. Co., Ltd. | Phase 2 |
Pharmacology for OXYBUTYNIN
Drug Class | Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for OXYBUTYNIN
Paragraph IV (Patent) Challenges for OXYBUTYNIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OXYTROL | Transdermal System Extended-release | oxybutynin | 3.9 mg/24 hrs | 021351 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharm Assoc | OXYBUTYNIN CHLORIDE | oxybutynin chloride | SYRUP;ORAL | 075137-001 | Dec 18, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-001 | Dec 16, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Impax Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 076745-001 | Nov 9, 2006 | DISCN | No | 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 |
Expired US Patents for OXYBUTYNIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OXYBUTYNIN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Teva B.V. | Kentera (previously Oxybutynin Nicobrand) | oxybutynin | EMEA/H/C/000532 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder. |
Authorised | no | no | no | 2004-06-15 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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