Vale Company Profile
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What is the competitive landscape for VALE, and what generic alternatives to VALE drugs are available?
VALE has eighty-one approved drugs.
There are six US patents protecting VALE drugs.
There are forty-four patent family members on VALE drugs in twelve countries and forty-one supplementary protection certificates in thirteen countries.
Summary for Vale
International Patents: | 44 |
US Patents: | 6 |
Tradenames: | 62 |
Ingredients: | 49 |
NDAs: | 81 |
Patent Litigation for Vale: | See patent lawsuits for Vale |
Drugs and US Patents for Vale
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Pharm Intl | TRISORALEN | trioxsalen | TABLET;ORAL | 012697-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Valeant Bermuda | PENLAC | ciclopirox | SOLUTION;TOPICAL | 021022-001 | Dec 17, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Valeant Intl | HYTONE | hydrocortisone | CREAM;TOPICAL | 080472-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Valeant Pharm Intl | BENDOPA | levodopa | CAPSULE;ORAL | 016948-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Valeant Pharm Intl | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 080592-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 Vale
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | 7,074,430 | ⤷ Sign Up |
Valeant Bermuda | PENLAC | ciclopirox | SOLUTION;TOPICAL | 021022-001 | Dec 17, 1999 | 4,957,730 | ⤷ Sign Up |
Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-003 | Dec 30, 1988 | 4,180,582 | ⤷ Sign Up |
Valeant Pharms North | DERMATOP | prednicarbate | OINTMENT;TOPICAL | 019568-001 | Sep 23, 1991 | 4,242,334 | ⤷ Sign Up |
Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-002 | Dec 30, 1988 | 5,114,948 | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for VALE drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Capsules | 75 mg | ➤ Subscribe | 2011-06-06 |
➤ Subscribe | Extended-release Tablets | 200 mg | ➤ Subscribe | 2007-03-28 |
➤ Subscribe | Tablets | 1.1 g | ➤ Subscribe | 2013-11-05 |
➤ Subscribe | Extended-release Tablets | 100 mg | ➤ Subscribe | 2007-01-08 |
➤ Subscribe | Extended-release Tablets | 300 mg | ➤ Subscribe | 2007-09-25 |
➤ Subscribe | Cream | 0.5% | ➤ Subscribe | 2011-07-29 |
International Patents for Vale Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 101247812 | ⤷ Sign Up |
China | 102670626 | ⤷ Sign Up |
Japan | 2013032395 | ⤷ Sign Up |
South Korea | 20090118906 | ⤷ Sign Up |
Mexico | 2009004826 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Vale Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 92401 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
1304992 | PA2013025,C1304992 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
1613296 | CR 2015 00042 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226 |
1539166 | 2013C/064 | Belgium | ⤷ Sign Up | PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626 |
0137963 | 97C0042 | Belgium | ⤷ Sign Up | PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.