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CUVPOSA Drug Profile
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Which patents cover Cuvposa, and what generic alternatives are available?
Cuvposa is a drug marketed by Merz Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in CUVPOSA is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
US ANDA Litigation and Generic Entry Outlook for Cuvposa
A generic version of CUVPOSA was approved as glycopyrrolate by AM REGENT on January 23rd, 2020.
Summary for CUVPOSA
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 76 |
| Patent Applications: | 2,536 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CUVPOSA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CUVPOSA |
| DailyMed Link: | CUVPOSA at DailyMed |
Recent Litigation for CUVPOSA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Merz Pharmaceuticals LLC v. Par Pharmaceutical Inc. | 2012-12-17 |
Synonyms for CUVPOSA
| .beta.-1-Methyl-3-pyrrolidyl-.alpha.-cyclopentylmandelate methobromide |
| (1,1-Dimethyl-2,3,4,5-tetrahydropyrrol-3-yl) 2-cyclopentyl-2-hydroxy-2-phenyl-acetate bromide |
| (1,1-Dimethyl-2,3,4,5-tetrahydropyrrol-3-yl) 2-cyclopentyl-2-hydroxy-2-phenyl-acetate bromide Glycopyrronium bromide |
| (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenyl-acetate |
| (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenyl-acetate bromide |
| (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate |
| (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate bromide |
| [(3S)-1,1-dimethylpyrrolidin-1-ium-3-yl] (2R)-2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide |
| 1-Methyl-3-pyrrolidinyl .alpha.-phenylcyclopentaneglycolate methobromide |
| 1-methyl-3-pyrrolidyl alpha-cyclopentylmandelate methobromide |
| 1-methyl-3-pyrrolidyl alpha-phenyl-alpha-cyclopentylglycolate methobromide |
| 1-Methyl-3-pyrrolidyl alpha-phenylcyclopentaneglycolate methobromide |
| 1,1-Dimethyl-3-hydroxypyrrolidinium bromide .alpha.-cyclopentylmandelate |
| 1,1-Dimethyl-3-hydroxypyrrolidinium bromide alpha-cyclopentylmandelate |
| 13283-82-4 |
| 2-cyclopentyl-2-hydroxy-2-phenylacetic acid (1,1-dimethyl-3-pyrrolidin-1-iumyl) ester |
| 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide |
| 3-(2-Cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidinium Bromide |
| 3-(2-phenyl-2-cyclopentylglycoloyloxy)-1,1-dimethylpyrrolidinium bromide |
| 3-(erythro-2-Cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidiniumbromid |
| 3-[(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidin-1-ium |
| 3-{[cyclopentyl(hydroxy)phenylacetyl]oxy}-1,1-dimethylpyrrolidin-1-ium bromide |
| 3-Hydroxy-1,1-dimethylpyrrolidinium bromide .alpha.-cyclopentylmandelate |
| 3-Hydroxy-1,1-dimethylpyrrolidinium bromide alpha-cyclopentylmandelate |
| 3-Hydroxy-1,1-dimethylpyrrolidinium bromide-.alpha.-cyclopentylmandelate |
| 475468-09-8 |
| 51186-83-5 |
| 53808-86-9 |
| 596-51-0 |
| 740028-90-4 |
| AB0010706 |
| AB00513912 |
| AB00513912_10 |
| AB00513912-08 |
| AC-23382 |
| AC1L1G28 |
| AC1L1XX0 |
| AC1LAW54 |
| AC1Q1RGS |
| AC1Q60WT |
| AD-237 |
| AHR 504 |
| AHR-504 |
| AKOS015962136 |
| alpha-cyclopentylmandelic acid ester with 3-hydroxy-1,1-dimethylpyrrolidinium bromide |
| AN-46262 |
| ANGKOCUUWGHLCE-UHFFFAOYSA-N |
| Asecryl |
| BC209826 |
| BCP07110 |
| BDBM50417445 |
| BPBio1_000806 |
| BRD-A81233518-004-07-0 |
| Bromure de glycopyrronium |
| Bromure de glycopyrronium [INN-French] |
| Bromure de ritropirronio |
| Bromure de ritropirronium |
| Bromuro de glicopirronio |
| Bromuro de glicopirronio [INN-Spanish] |
| BSPBio_000732 |
| C19H28BrNO3 |
| C19H28NO3 |
| CAS-596-51-0 |
| CCG-101030 |
| CCG-213543 |
| CHEBI:90972 |
| CHEBI:94449 |
| CHEMBL1201027 |
| CHEMBL1201335 |
| CHF-5992 |
| Copyrrolate |
| CPD000469282 |
| CS-1763 |
| CTK0F4931 |
| Cuvposa (TN) |
| D00540 |
| D10938 |
| DSSTox_CID_3109 |
| DSSTox_GSID_23109 |
| DSSTox_RID_76878 |
| DTXSID2048165 |
| DTXSID6023109 |
| EINECS 209-887-0 |
| erythro-3-Hydroxy-1,1-dimethylpyrrolidinium bromide alpha-cyclopentylmandelate |
| erythro-3-Hydroxy-1,1-dimethylpyrrolidinium bromide alpha-cyclopentylmandelate. |
| FT-0626787 |
| G00010-Watson-Int |
| G0392 |
| Gastrodyn |
| GLYCOPYRROLATE |
| Glycopyrrolate (USP) |
| Glycopyrrolate [USAN:USP] |
| Glycopyrrolate [USAN] |
| Glycopyrrolate bromide |
| Glycopyrrolate, >=98% (HPLC) |
| Glycopyrrolate, United States Pharmacopeia (USP) Reference Standard |
| GLYCOPYRRONE BROMIDE |
| Glycopyrroni bromidum |
| Glycopyrronii bromidum |
| Glycopyrronii bromidum [INN-Latin] |
| Glycopyrronium |
| Glycopyrronium (USAN) |
| glycopyrronium bromide |
| Glycopyrronium Bromide ,(S) |
| Glycopyrronium bromide (JAN/INN) |
| Glycopyrronium bromide, European Pharmacopoeia (EP) Reference Standard |
| Glycopyrronium for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Glycopyrronium impurity N, European Pharmacopoeia (EP) Reference Standard |
| GTPL7459 |
| HMS1570E14 |
| HMS2051P12 |
| HMS2094A05 |
| HMS2097E14 |
| HMS2235F12 |
| HMS3259P04 |
| HMS3369F10 |
| HMS3393P12 |
| HMS3714E14 |
| HY-17465 |
| I14-3643 |
| L001045 |
| Lonhala Magnair |
| LS-138344 |
| Mandelic acid, ester with 3-hydroxy-1,1-dimethylpyrrolidinium bromide |
| MFCD00072137 |
| MLS001424112 |
| MLS002222301 |
| MolPort-006-112-011 |
| MRF-0000310 |
| NC00280 |
| NC00694 |
| NCGC00179456-01 |
| NCGC00179456-02 |
| NCGC00179456-04 |
| Nodapton |
| Nodapton|||Robanul|||Robinul|||Tarodyl|||Tarodyn |
| NSC 250836 |
| NSC 251251 |
| NSC 251252 |
| NSC-250836 |
| NSC-251251 |
| NSC-251252 |
| NSC-759238 |
| NSC250836 |
| NSC251251 |
| NSC251252 |
| NSC759238 |
| NVA 237 |
| NVA-237 |
| OR315526 |
| Pharmakon1600-01505753 |
| Prestwick0_000746 |
| Prestwick1_000746 |
| Prestwick2_000746 |
| Prestwick3_000746 |
| PT-001 |
| Pyrrolidinium, 1,1-dimethyl-3-hydroxy-, bromide, alpha-cyclopentylmandelate |
| Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, bromide |
| Pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl- |
| Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, bromide, .alpha.-cyclopentylmandelate |
| Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, bromide, alpha-cyclopentylmandelate |
| Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, bromide, alpha-cyclopentylmandelate (8CI) |
| Pyrrolidinium,1-dimethyl-, bromide |
| Pyrrolidinium,1-dimethyl-, bromide, .alpha.-cyclopentylmandelate |
| Qbrexza® (glycopyrronium cloth) |
| Ritropirronium bromide |
| Ritropirronium bromide [INN] |
| RL04249 |
| Robanul |
| Robinal |
| Robinul |
| Robinul (TN) |
| ROBINUL FORTE |
| s4660 |
| SAM001246629 |
| SAM002589987 |
| SBI-0206947.P001 |
| SCHEMBL133002 |
| SCHEMBL41436 |
| Seebri |
| Seebri Breezhaler |
| Seebri breezhaler (TN) |
| Seebri Neohaler |
| SMR000469282 |
| SPBio_002671 |
| SR-01000763650 |
| SR-01000763650-3 |
| ST24047338 |
| Tarodyl |
| Tarodyn |
| Tovanor Breezhaler |
| Tox21_113144 |
| Tox21_113144_1 |
| Tox21_113145 |
| VPNYRYCIDCJBOM-UHFFFAOYSA-M |
| WLN: T5KTJ A1 A1 COVXQR&- AL5TJ &Q &E |
| ZLA0012 |
| zlchem 10 |
Paragraph IV (Patent) Challenges for CUVPOSA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CUVPOSA | SOLUTION;ORAL | glycopyrrolate | 022571 | 2012-06-20 |
US Patents and Regulatory Information for CUVPOSA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merz Pharms | CUVPOSA | glycopyrrolate | SOLUTION;ORAL | 022571-001 | Jul 28, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Merz Pharms | CUVPOSA | glycopyrrolate | SOLUTION;ORAL | 022571-001 | Jul 28, 2010 | RX | Yes | Yes | 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 |
