Oxybutynin chloride - Generic Drug Details
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What are the generic sources for oxybutynin chloride and what is the scope of patent protection?
Oxybutynin chloride
is the generic ingredient in four branded drugs marketed by 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, Trupharma, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in thirty-eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Oxybutynin chloride has twenty-two patent family members in thirteen countries.
There are nine drug master file entries for oxybutynin chloride. Forty suppliers are listed for this compound.
Summary for oxybutynin chloride
International Patents: | 22 |
US Patents: | 3 |
Tradenames: | 4 |
Applicants: | 32 |
NDAs: | 38 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 40 |
Raw Ingredient (Bulk) Api Vendors: | 111 |
Clinical Trials: | 23 |
Patent Applications: | 2,577 |
Drug Prices: | Drug price trends for oxybutynin chloride |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxybutynin chloride |
What excipients (inactive ingredients) are in oxybutynin chloride? | oxybutynin chloride excipients list |
DailyMed Link: | oxybutynin chloride at DailyMed |
Recent Clinical Trials for oxybutynin chloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Seoul National University Hospital | Phase 2 |
Il-Yang Pharm. Co., Ltd. | Phase 2 |
National Cancer Institute (NCI) | Phase 2 |
Pharmacology for oxybutynin chloride
Drug Class | Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for oxybutynin chloride
Paragraph IV (Patent) Challenges for OXYBUTYNIN CHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GELNIQUE | Gel | oxybutynin chloride | 10% | 022204 | 1 | 2014-06-19 |
US Patents and Regulatory Information for oxybutynin chloride
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 | ||||
Zydus Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 202332-002 | Jun 26, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 202332-001 | Jun 26, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 209025-002 | Feb 7, 2023 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pharm Assoc | OXYBUTYNIN CHLORIDE | oxybutynin chloride | SYRUP;ORAL | 074997-001 | Oct 15, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Beximco Pharms Usa | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 213550-001 | Jul 14, 2022 | AB | RX | 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 chloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-003 | Jun 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-001 | Dec 16, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-001 | Dec 16, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-003 | Jun 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-002 | Dec 16, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxybutynin chloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 10772664 | ⤷ Sign Up | |
China | 102421411 | A method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions | ⤷ Sign Up |
Japan | 2012526124 | ⤷ Sign Up | |
Japan | 5795817 | ⤷ Sign Up | |
Brazil | PI1015542 | um método para tratar bexigas hiperativas e um dispositivo para armazenamento e administração de composições tópicas de oxibutinina | ⤷ Sign Up |
Mexico | 338166 | UN PROCEDIMIENTO PARA TRATAR VEJIGAS HIPERACTIVAS Y UN DISPOSITIVO PARA ALMACENAMIENTO Y ADMINISTRACION DE COMPOSICIONES TOPICAS DE OXIBUTININA. (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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