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Guanfacine hydrochloride - Generic Drug Details
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What are the generic drug sources for guanfacine hydrochloride and what is the scope of guanfacine hydrochloride patent protection?
Guanfacine hydrochloride
is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Apotex Inc, Impax Labs Inc, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, Twi Pharms, Shire, Amneal Pharm, Epic Pharma Llc, Mylan, Watson Labs, and Promius Pharma, and is included in fifteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Guanfacine hydrochloride has ten patent family members in nine countries.
There are seven drug master file entries for guanfacine hydrochloride. Twenty-four suppliers are listed for this compound.
Summary for guanfacine hydrochloride
| International Patents: | 10 |
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 14 |
| NDAs: | 15 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 24 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 55 |
| Patent Applications: | 845 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for guanfacine hydrochloride |
| DailyMed Link: | guanfacine hydrochloride at DailyMed |
Pharmacology for guanfacine hydrochloride
| Drug Class | Central alpha-2 Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for guanfacine hydrochloride
Synonyms for guanfacine hydrochloride
| [(2,6-Dichlorophenyl)acetyl]guanidine Hydrochloride |
| 29110-47-2 (Parent) |
| 29110-48-3 |
| 29520-14-7 |
| A826918 |
| AB0011596 |
| AC1L2G3E |
| AC1Q3P39 |
| AK105076 |
| AKOS015966858 |
| AKOS030242245 |
| ANW-70740 |
| API0006740 |
| AS-12253 |
| AX8239284 |
| BC202678 |
| Benzeneacetamide, N-(aminoiminomethyl)-2,6-dichloro-, hydrochloride (1:1) |
| Benzeneacetamide, N-(aminoiminomethyl)-2,6-dichloro-, monohydrochloride |
| BG0397 |
| BS 100-141 |
| BS-100-141 |
| C9H10Cl3N3O |
| C9H9Cl2N3O.HCl |
| CAS-29520-14-7 |
| CCG-213439 |
| CCG-220339 |
| CHEBI:5559 |
| CHEMBL1200494 |
| Connexyn |
| CS-1254 |
| CTK8C3871 |
| CTK8G0106 |
| D00606 |
| D0WD8M |
| DSSTox_CID_25157 |
| DSSTox_GSID_45157 |
| DSSTox_RID_80708 |
| DTXSID2045157 |
| EINECS 249-443-3 |
| Estulic |
| EU-0100519 |
| FT-0630546 |
| FT-0698181 |
| G 1043 |
| G0414 |
| Guanfacin |
| Guanfacin hydrochloride |
| Guanfacine (hydrochloride) |
| GUANFACINE HCL |
| Guanfacine hydrochloride (JAN/USP) |
| Guanfacine hydrochloride [USAN:JAN] |
| Guanfacine hydrochloride [USAN:USP:JAN] |
| Guanfacine hydrochloride, >=98% (HPLC) |
| Guanfacine hydrochloride, pharmaceutical secondary standard; traceable to USP |
| Guanfacine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| GUANFACINEHCL |
| GuanfacineHydrochloride |
| Guanfascine Hydrochloride |
| Guarfacine Hydrochloride |
| HMS1569C19 |
| HY-17416 |
| Intuniv |
| J-017395 |
| KB-258655 |
| KS-000017QB |
| LON 798 |
| LP00519 |
| LS-28474 |
| MFCD00798230 |
| MLS000069745 |
| MLS001077329 |
| MLS002222252 |
| MolPort-003-666-686 |
| MolPort-019-997-499 |
| N (Aminoiminomethyl)-2,6-dichlorobenzeneacetamide |
| N-(aminoiminomethyl)-2,6-dichloro-benzeneacetamide hydrochloride |
| N-(Aminoiminomethyl)-2,6-dichlorobenzeneacetamide hydrochloride |
| N-(Aminoiminomethyl)-2,6-dichlorophenylacetamide monohydrochloride |
| N-(diaminomethylidene)-2-(2,6-dichlorophenyl)acetamide hydrochloride |
| N-[bis(azanyl)methylidene]-2-[2,6-bis(chloranyl)phenyl]ethanamide hydrochloride |
| N-Amidino-2-(2,6-dichlorophenyl)acetamide hydrochloride |
| N-Amidino-2-(2,6-dichlorophenyl)acetamide monohydrochloride |
| N-Carbamimidoyl-2-(2,6-dichlorophenyl)acetamide hydrochloride |
| n-carbamimidoyl-2-(2,6-dichlorphenyl)acetamidhydrochlorid |
| NCGC00015469-05 |
| NCGC00015469-09 |
| NCGC00093914-01 |
| NCGC00093914-02 |
| NCGC00180965-01 |
| NCGC00261204-01 |
| NSC-759121 |
| NSC759121 |
| Opera_ID_1928 |
| Pharmakon1600-01505435 |
| PML56A160O |
| Prestwick_740 |
| S-877503 |
| s4693 |
| SCHEMBL15603414 |
| SCHEMBL41681 |
| SMR000058453 |
| SPD 503 |
| SPD-503 |
| SPD503 |
| SR-01000075893 |
| SR-01000075893-1 |
| TC-159485 |
| Tenex |
| Tenex (TN) |
| Tox21_110159 |
| Tox21_110159_1 |
| Tox21_500519 |
| UNII-PML56A160O |
| W-5123 |
US Patents and Regulatory Information for guanfacine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-004 | Sep 2, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Teva Pharms Usa | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201382-004 | Jun 2, 2015 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Impax Labs Inc | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202238-002 | Oct 20, 2015 | DISCN | 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 |
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Expired US Patents for guanfacine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-003 | Sep 2, 2009 | ➤ Sign Up | ➤ Sign Up |
| Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-001 | Sep 2, 2009 | ➤ Sign Up | ➤ Sign Up |
| Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-001 | Oct 27, 1986 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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International Patents for guanfacine hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2004518676 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 02058676 | ➤ Sign Up |
| Portugal | 1351668 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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