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Ropinirole hydrochloride - Generic Drug Details
What are the generic drug sources for ropinirole hydrochloride and what is the scope of freedom to operate?
Ropinirole hydrochloride
is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic Pharms Ltd, Celltrion, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Acp Nimble, Alembic Ltd, Cadila, Epic Pharma Llc, Glenmark Generics, Hikma, MLV, Mylan, Orchid Hlthcare, and Prinston Inc, and is included in twenty-one NDAs. There are two patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ropinirole hydrochloride has fifty-one patent family members in twenty-seven countries.
There are fourteen drug master file entries for ropinirole hydrochloride. Twenty-five suppliers are listed for this compound.
Summary for ropinirole hydrochloride
| International Patents: | 51 |
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 19 |
| NDAs: | 21 |
| Drug Master File Entries: | 14 |
| Suppliers / Packagers: | 25 |
| Bulk Api Vendors: | 106 |
| Clinical Trials: | 73 |
| Patent Applications: | 1,866 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ropinirole hydrochloride |
| DailyMed Link: | ropinirole hydrochloride at DailyMed |
Recent Clinical Trials for ropinirole hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Population Health Research Institute | Phase 3 |
| University of Alberta | Phase 4 |
| Titan Pharmaceuticals | Phase 1/Phase 2 |
Recent Litigation for ropinirole hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| Sanofi-Aventis v. Wockhardt Limited | 2008-03-14 |
| Plaintiff(s) v. Defendant(s) | 2008-01-31 |
Pharmacology for ropinirole hydrochloride
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
Synonyms for ropinirole hydrochloride
| 1,3-Dihydro-4-(2-(dipropylamino)ethyl)-2H-indol-2-one monohydrochloride |
| 2(H)-Indol-2-one, 4-(2-(dipropylamino)ethyl)-1,3-dihydro-, monohydrochloride |
| 2H-Indol-2-one, 1,3-dihydro-4-(2-(dipropylamino)ethyl)-, monohydrochloride |
| 374R208 |
| 4-(2-(Dipropylamino)ethyl)-2-indolinone monohydrochloride |
| 4-(2-(Dipropylamino)ethyl)indolin-2-one hydrochloride |
| 4-(2-di-n-propylaminoethyl)-2(3H)-indolone hydrochloride |
| 4-(2-di-n-propylaminoethyl)-2(3H)indolone hydrochloride |
| 4-(2-dipropylaminoethyl)-1,3-dihydroindol-2-one hydrochloride |
| 4-[2-(Di-n-propylamino)ethyl]-2(3H)-indolone Hydrochloride |
| 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride |
| 4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one hydrochloride |
| 4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one;hydrochloride |
| 4-[2-(dipropylamino)ethyl]-2,3-dihydro-1H-indol-2-one hydrochloride |
| 4-[2-(dipropylamino)ethyl]indolin-2-one hydrochloride |
| 4CA-1107 |
| 91374-20-8 |
| 91374-20-8,91374-21-9(freebase) |
| 91374-21-9 (base) |
| 91374-21-9 (Parent) |
| A843815 |
| AB0009822 |
| ABP000199 |
| AC-735 |
| AC-736 |
| AC1L2ABS |
| AC1Q3EQJ |
| ACT02690 |
| Adartrel |
| AKOS015844988 |
| AN-15584 |
| ANW-58872 |
| BC207366 |
| BCP02130 |
| BS-1020 |
| CCG-213346 |
| CHEBI:8889 |
| CHEMBL1200411 |
| CS-2864 |
| CTK8B7890 |
| D00784 |
| D7ZD41RZI9 |
| DTXSID50238533 |
| EBD38503 |
| EU-0101101 |
| FC0024 |
| FT-0642200 |
| HP-3000 |
| HY-B0623A |
| I06-0693 |
| JZP-7 |
| KB-80420 |
| KS-000011L6 |
| KS-00002WRZ |
| LP01101 |
| LS-83828 |
| M-1298 |
| MCULE-8190476072 |
| MFCD01754173 |
| MLS003899234 |
| MolPort-003-987-439 |
| NCGC00094373-01 |
| NCGC00261786-01 |
| NP-201 |
| NVD-434 |
| R 4152 |
| Repreve |
| Requi |
| ReQuip |
| Requip (TN) |
| ReQuip CR |
| ReQuip LP |
| ReQuip PR |
| ReQuip XL |
| ReQuip XR |
| Ropinirole (hydrochloride) |
| Ropinirole for peak identification 1, EuropePharmacopoeia (EP) Reference Standard |
| Ropinirole for peak identification 2, EuropePharmacopoeia (EP) Reference Standard |
| Ropinirole HCl |
| Ropinirole hydrochloride (JAN/USAN) |
| Ropinirole hydrochloride [USAN:USP] |
| Ropinirole hydrochloride [USAN] |
| Ropinirole hydrochloride, EuropePharmacopoeia (EP) Reference Standard |
| Ropinirole Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
| Ropinirole hydrochloride, powder, >=98% (HPLC) |
| Ropinirole hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Ropinirole hydrochloride; |
| Ropinirole hydrochloride/ |
| Ropinirolhydrochloride |
| s3189 |
| SCHEMBL40760 |
| SK&F 101468-A |
| SK&F-101468-A |
| SK&F-101468A |
| SKF 101468 hydrochloride |
| SKF 101468; 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride |
| SKF-101468A |
| SMR001456484 |
| SR-01000076215 |
| SR-01000076215-2 |
| SR-01000076215-5 |
| ST24042825 |
| SW199044-2 |
| TC-030791 |
| TL8005858 |
| Tox21_501101 |
| UNII-D7ZD41RZI9 |
| XDXHAEQXIBQUEZ-UHFFFAOYSA-N |
| Z1695926158 |
Paragraph IV (Patent) Challenges for ROPINIROLE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-07-14 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-02-05 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-01-08 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-11-03 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-10-31 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-10-14 |
| REQUIP | TABLET;ORAL | ropinirole hydrochloride | 020658 | 2005-02-04 |
| REQUIP | TABLET;ORAL | ropinirole hydrochloride | 020658 | 2004-12-22 |
US Patents and Regulatory Information for ropinirole hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cadila | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 090411-002 | Jun 1, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 078881-004 | May 5, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Pharms Inc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200462-003 | Oct 15, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sandoz Inc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201047-006 | Jun 6, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Accord Hlthcare | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 204022-002 | Feb 28, 2017 | 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 ropinirole hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-003 | Sep 19, 1997 | Start Trial | Start Trial |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-007 | Jan 27, 1999 | Start Trial | Start Trial |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-001 | Jun 13, 2008 | Start Trial | Start Trial |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | Start Trial | Start Trial |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-004 | Sep 19, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ropinirole hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2003530423 | Start Trial |
| South Korea | 20080047630 | Start Trial |
| Cyprus | 1108440 | Start Trial |
| European Patent Office | 1272167 | Start Trial |
| Italy | MI20000852 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ropinirole hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0299602 | SPC/GB96/040 | United Kingdom | Start Trial | PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702 |
| 0299602 | 97C0036 | Belgium | Start Trial | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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