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-two 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-five supplementary protection certificates in thirteen countries.
Summary for Vale
| International Patents: | 44 |
| US Patents: | 6 |
| Tradenames: | 63 |
| Ingredients: | 50 |
| NDAs: | 82 |
| 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 Bermuda | DERMATOP E EMOLLIENT | prednicarbate | CREAM;TOPICAL | 020279-001 | Oct 29, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Pharm Intl | BENDOPA | levodopa | CAPSULE;ORAL | 016948-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Pharm Intl | LIBRIUM | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 012249-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Pharm Intl | FLUOXYMESTERONE | fluoxymesterone | TABLET;ORAL | 088221-001 | May 5, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Pharm Intl | ANDROID-F | fluoxymesterone | TABLET;ORAL | 087196-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Intl | RETIN-A | tretinoin | SOLUTION;TOPICAL | 016921-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a 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 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 | ⤷ Try a Trial |
| Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-002 | Dec 30, 1988 | 4,797,405 | ⤷ Try a Trial |
| Valeant Luxembourg | VISUDYNE | verteporfin | INJECTABLE;INJECTION | 021119-001 | Apr 12, 2000 | 5,770,619 | ⤷ Try a Trial |
| Valeant Luxembourg | VISUDYNE | verteporfin | INJECTABLE;INJECTION | 021119-001 | Apr 12, 2000 | 5,756,541 | ⤷ Try a Trial |
| Valeant Intl | RETIN-A | tretinoin | SOLUTION;TOPICAL | 016921-001 | Approved Prior to Jan 1, 1982 | 3,729,568 | ⤷ Try a Trial |
| Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017579-002 | Approved Prior to Jan 1, 1982 | 3,729,568 | ⤷ Try a Trial |
| >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 | 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 |
| ➤ 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 |
International Patents for Vale Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 3004028 | ⤷ Try a Trial |
| Japan | 2013032395 | ⤷ Try a Trial |
| New Zealand | 593132 | ⤷ Try a Trial |
| European Patent Office | 2096912 | ⤷ Try a Trial |
| Brazil | PI0717859 | ⤷ Try a Trial |
| Denmark | 2096912 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Vale Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | PA2013025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
| 1539166 | 13C0062 | France | ⤷ Try a Trial | PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626 |
| 1586316 | 122011100019 | Germany | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
| 1667986 | 92172 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL) |
| 0809498 | SPC/GB10/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
| 0566709 | SPC/GB04/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
