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Ropinirole hydrochloride - Generic Drug Details
What are the generic sources for ropinirole hydrochloride and what is the scope of ropinirole hydrochloride freedom to operate?
Ropinirole hydrochloride
is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Wockhardt Ltd, Accord Hlthcare, Alembic Ltd, Apotex, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Mylan, Orchid Hlthcare, Prinston Inc, West-ward Pharms Int, Wockhardt, and Zydus Pharms Usa 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 patent family members in twenty-seven countries.
There are fourteen drug master file entries for ropinirole hydrochloride. Thirty suppliers are listed for this compound.
Summary for ropinirole hydrochloride
| International Patents: | 50 |
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 20 |
| NDAs: | 21 |
| Drug Master File Entries: | 14 |
| Suppliers / Packagers: | 30 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 72 |
| Patent Applications: | 1,721 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ropinirole hydrochloride |
| DailyMed Link: | ropinirole hydrochloride at DailyMed |
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-(Dipropylamino)ethyl)indolin-2-onehydrochloride |
| 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 |
| AK-59618 |
| AKOS015844988 |
| AN-15584 |
| ANW-58872 |
| BC207366 |
| 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 |
| Requip (TN) |
| ReQuip LP |
| ReQuip PR |
| 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; traceable to USP, PhEur |
| Ropinirole hydrochloride, powder, >=98% (HPLC) |
| Ropinirole hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Ropinirole hydrochloride; |
| Ropinirole hydrochloride/ |
| Ropinirolehydrochloride |
| 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 |
| ST24042825 |
| ST51051236 |
| TC-030791 |
| TL8005858 |
| Tox21_501101 |
| UNII-D7ZD41RZI9 |
| XDXHAEQXIBQUEZ-UHFFFAOYSA-N |
| Z1695926158 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wockhardt | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 079050-007 | May 29, 2008 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Wockhardt Ltd | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091395-002 | Aug 27, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| G And W Labs Inc | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 077460-007 | May 19, 2008 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Wockhardt | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 079050-005 | May 29, 2008 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Mylan | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 078881-004 | May 5, 2008 | 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 ropinirole hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-001 | Sep 19, 1997 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-003 | Jun 13, 2008 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-002 | Sep 19, 1997 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-001 | Jun 13, 2008 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-003 | Sep 19, 1997 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-004 | Sep 19, 1997 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ropinirole hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 4857601 | ➤ Sign Up |
| European Patent Office | 2343060 | ➤ Sign Up |
| South Korea | 20070065922 | ➤ Sign Up |
| Poland | 365837 | ➤ Sign Up |
| Italy | 1318687 | ➤ Sign Up |
| Austria | 401867 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ropinirole hydrochloride
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0036 | Belgium | ➤ Sign Up | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 |
| C/GB96/040 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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