DrugPatentWatch Database Preview
GELNIQUE Drug Profile
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When do Gelnique patents expire, and when can generic versions of Gelnique launch?
Gelnique is a drug marketed by Allergan Sales Llc and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-one patent family members in twenty countries.
The generic ingredient in GELNIQUE is oxybutynin. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxybutynin profile page.
Summary for GELNIQUE
| International Patents: | 81 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 3 |
| Patent Applications: | 1,425 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GELNIQUE |
| DailyMed Link: | GELNIQUE at DailyMed |
Pharmacology for GELNIQUE
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Synonyms for GELNIQUE
| (R,S) - Oxybutynin Hydrochloride |
| (R)-|A-Phenylcyclohexaneglycolic Acid 4-(Diethylamino)-2-butynyl Ester, Hydrochloride |
| (R)-OXYBUTYNIN HYDROCHLORIDE |
| (S)-|A-Phenylcyclohexaneglycolic Acid 4-(Diethylamino)-2-butynyl Ester, Hydrochloride |
| (s)-oxybutynin chloride |
| 1508-65-2 |
| 2-cyclohexyl-2-hydroxy-2-phenylacetic acid 4-(diethylamino)but-2-ynyl ester hydrochloride |
| 4-(Diethylamino)-2-butynyl (+-)-alpha-phenylcyclohexaneglycolate hydrochloride |
| 4-(Diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolate hydrochloride |
| 4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate hydrochloride |
| 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenyl-acetate hydrochloride |
| 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate hydrochloride |
| 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate, chloride |
| 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride |
| 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-oxidanyl-2-phenyl-ethanoate hydrochloride |
| 4-(Diethylamino)but-2-ynyl cyclohexylphenylglycolate hydrochloride |
| 4-Diethylamino-2-butynyl phenyl(cyclohexyl)glycolate hydrochloride |
| 5633-20-5 (Parent) |
| A809082 |
| AC1L3M7P |
| AK142874 |
| AKOS015895349 |
| alpha-Phenylcyclohexaneglycolic acid 4-(diethylamino)-2-butynyl ester hydrochloride |
| AN-49346 |
| API0003718 |
| Benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester hydrochloride |
| Benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester hydrochloride, (+-)- |
| BG0595 |
| C-21602 |
| C22H31NO3.HCl |
| C22H32ClNO3 |
| CAS-1508-65-2 |
| CCG-213420 |
| CHEBI:7857 |
| CHEMBL1133 |
| CPD000058490 |
| CS-2256 |
| CTK8G2229 |
| Cyclohexaneglycolic acid, alpha-phenyl-, 4-(diethylamino)-2-butynyl ester, hydrochloride |
| D00722 |
| D05KZK |
| D0R1DH |
| Ditropan (TN) |
| Ditropan Xl |
| DL-06003 |
| Dridase |
| DSSTox_CID_25356 |
| DSSTox_GSID_45356 |
| DSSTox_RID_80822 |
| DTXSID3045356 |
| EINECS 216-139-7 |
| EU-0100923 |
| FT-0082889 |
| FT-0603563 |
| Gelnique (TN) |
| H33O205 |
| H815 |
| HMS1568J16 |
| HOB-294 |
| HY-B0267A |
| I06-0708 |
| J-008750 |
| J10411 |
| Jsp002882 |
| KS-00000ZDA |
| KS-1377 |
| LP00923 |
| LP052649 |
| LS-56862 |
| MCULE-5193326065 |
| MFCD00072150 |
| MJ 4309-1 |
| MJ-4309-1 |
| MLS000069688 |
| MLS001148211 |
| MLS002222232 |
| MolPort-003-666-668 |
| NC00580 |
| NCGC00016583-01 |
| NCGC00094234-01 |
| NCGC00094234-02 |
| NCGC00261608-01 |
| NSC-759108 |
| NSC759108 |
| O 2881 |
| Opera_ID_1330 |
| OR009708 |
| OR206939 |
| Oxibutinina hydrochloride |
| Oxybutynin (chloride) |
| Oxybutynin chloride |
| Oxybutynin chloride (USP) |
| Oxybutynin chloride [USAN:USP] |
| Oxybutynin chloride [USAN] |
| Oxybutynin chloride, >=98% (TLC), powder |
| Oxybutynin chloride, meets EP, USP testing specifications |
| Oxybutynin chloride, United States Pharmacopeia (USP) Reference Standard |
| Oxybutynin HCl |
| Oxybutynin hydrochloride |
| Oxybutynin hydrochloride (JAN) |
| Oxybutynin hydrochloride (transdermal patch, overactive bladder) |
| Oxybutynin hydrochloride (transdermal patch, overactive bladder), Hisamitsu |
| Oxybutynin hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Oxybutyninhydrochloride |
| Pharmakon1600-01505399 |
| Prestwick_621 |
| REGID_for_CID_91505 |
| s3117 |
| SAM002564226 |
| SC-18892 |
| SCHEMBL25751 |
| SMR000058490 |
| SMT-D002 |
| SR-01000000184 |
| SR-01000000184-2 |
| ST24048864 |
| ST51015085 |
| SWIJYDAEGSIQPZ-UHFFFAOYSA-N |
| Tox21_110507 |
| Tox21_500923 |
| Tropax |
| VA11467 |
US Patents and Regulatory Information for GELNIQUE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan Sales Llc | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Allergan Sales Llc | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Allergan Sales Llc | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Allergan Sales Llc | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Allergan Sales Llc | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Allergan Sales Llc | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | AB | RX | Yes | Yes | ➤ 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 |
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Paragraph IV (Patent) Challenges for GELNIQUE
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Gel | 10% | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for GELNIQUE
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,743,441 | Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy | ➤ Sign Up |
| 7,081,252 | Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy | ➤ Sign Up |
| 7,081,250 | Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy | ➤ Sign Up |
| 7,081,249 | Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy | ➤ Sign Up |
| 7,081,251 | Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy | ➤ Sign Up |
| 7,087,241 | Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for GELNIQUE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Norway | 20052625 | ➤ Sign Up |
| Japan | 2013082720 | ➤ Sign Up |
| Denmark | 1280486 | ➤ Sign Up |
| Canada | 2718277 | ➤ Sign Up |
| Mexico | PA05004110 | ➤ Sign Up |
| Mexico | 342305 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
