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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, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Arise, Athem, Emcure Pharms Ltd, Novast Labs, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in thirty-seven 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 sixteen patent family members in twenty-two countries.
There are sixteen drug master file entries for oxybutynin. Two suppliers are listed for this compound.
Summary for oxybutynin
| International Patents: | 116 |
| US Patents: | 13 |
| Tradenames: | 8 |
| Applicants: | 31 |
| NDAs: | 37 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 79 |
| Patent Applications: | 5,452 |
| 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 Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
| University of Arizona | Phase 2 |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | N/A |
Recent Litigation for oxybutynin
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Auxilium Pharmaceuticals v. Upsher-Smith Laboratories | 2014-01-29 |
| Abbott Products Inc. v. Teva Pharamceuticals USA, Inc. | 2011-04-29 |
Pharmacology for oxybutynin
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Synonyms for oxybutynin
| (+/-)-oxybutynin |
| (+/-)-OXYBUTYNIN(Hydrochloride form) |
| (R)-4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate |
| 1508-65-2 (hydrochloride) |
| 27815-EP2269989A1 |
| 27815-EP2275420A1 |
| 27815-EP2280008A2 |
| 27815-EP2298767A1 |
| 27815-EP2314587A1 |
| 4-(Diethylamino)-2-butynyl .alpha.-phenylcyclohexaneglycolate |
| 4-(Diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolic acid ester |
| 4-(Diethylamino)-2-butynyl cyclohexyl(hydroxy)phenylacetate # |
| 4-(diethylamino)-2-butynyl-alpha-cyclohexyl-alpha-hydroxybenzeneacetate |
| 4-(diethylamino)-2-butynyl-alpha-phenylcyclohexaneglycolate |
| 4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate |
| 4-(diethylamino)but-2-yn-1-yl cyclohexyl(hydroxy)phenylacetate |
| 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenyl-acetate |
| 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate |
| 4-Diethylamino-2-butinyl alpha-cyclohexylmandelat |
| 4-Diethylamino-2-butynyl alpha-phenylcyclohexaneglycolate |
| 4-diethylaminobut-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate |
| 5633-20-5 |
| 633O205 |
| AB0013281 |
| AB2000274 |
| AC-2153 |
| AC1L1ILV |
| AK162584 |
| AKOS015896242 |
| AN-14276 |
| Anturol |
| Anturol (TN) |
| API0007236 |
| AX8146542 |
| BCP12179 |
| BDBM50165019 |
| Benzeneacetic acid, a-cyclohexyl-a-hydroxy-,4-(diethylamino)-2-butynyl ester |
| Benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester |
| BPBio1_000214 |
| BRD-A65013509-003-03-8 |
| BRD-A65013509-003-13-7 |
| BSPBio_000194 |
| C-20821 |
| C07360 |
| CC-33425 |
| CCG-205005 |
| CCRIS 1923 |
| CHEBI:7856 |
| CHEMBL1231 |
| CS-2255 |
| Cyclohexaneglycolic acid, .alpha.-phenyl-, 4-(diethylamino)-2-butynyl ester |
| Cyclohexaneglycolic acid, alpha-phenyl-, 4-(diethylamino)-2-butynyl ester |
| Cystrin |
| D00465 |
| DB01062 |
| Ditropan |
| Ditropan Xl |
| Ditropan;Lyrinel XL;Oxytrol |
| DTXSID0023406 |
| FT-0082890 |
| FT-0603679 |
| GTPL359 |
| HSDB 3270 |
| HY-B0267 |
| I06-2117 |
| K-9978 |
| KS-00000GVI |
| KS-5221 |
| L000923 |
| Lopac0_000923 |
| LS-28714 |
| Lyrinel XL |
| MCULE-3407007074 |
| MFCD00865252 |
| MLS006010052 |
| MolPort-003-849-741 |
| MRF-0000601 |
| NCGC00015767-03 |
| NCGC00015767-04 |
| NCGC00015767-06 |
| NCGC00015767-07 |
| NCGC00015767-09 |
| NCGC00089795-02 |
| O222 |
| Oxibutinina |
| Oxibutinina [INN-Spanish] |
| Oxibutyninum |
| Oxybutinin |
| Oxybutynin (Ditropan) |
| Oxybutynin (USAN/INN) |
| Oxybutynin [USAN:INN:BAN] |
| Oxybutynin Base |
| oxybutynin topical gel |
| Oxybutynin transdermal |
| Oxybutynin transdermal patch |
| OXYBUTYNIN, Oxybutynin chloride |
| Oxybutynine |
| Oxybutynine [INN-French] |
| Oxybutyninum |
| Oxybutyninum [INN-Latin] |
| Oxytrol |
| Oxytrol (TN) |
| Oxytrol for Women |
| Pollakisu |
| Prestwick0_000287 |
| Prestwick1_000287 |
| Prestwick2_000287 |
| Prestwick3_000287 |
| s1754 |
| SBI-0050898.P002 |
| SC-26752 |
| SCHEMBL2992 |
| SMR001550466 |
| SPBio_002413 |
| ST24048863 |
| SW196787-3 |
| transdermal patch |
| XIQVNETUBQGFHX-UHFFFAOYSA-N |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 072485-001 | Apr 19, 1989 | 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 | ||||
| Vintage Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 075079-001 | Oct 31, 1997 | AB | RX | No | Yes | 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 | |||
| Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503-001 | Feb 4, 2009 | 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 | 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 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxybutynin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2004505931 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0211768 | Start Trial |
| Germany | 60143477 | Start Trial |
| Austria | 485837 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2004041187 | Start Trial |
| Germany | 60127134 | Start Trial |
| Japan | 2003531157 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.