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 | DALMANE | flurazepam hydrochloride | CAPSULE;ORAL | 016721-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
Valeant Pharms North | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 075116-002 | Dec 23, 1999 | AB3 | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
Valeant Pharm Intl | LIBRIUM | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 012249-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | |||||
Valeant Bermuda | DERMATOP E EMOLLIENT | prednicarbate | CREAM;TOPICAL | 020279-001 | Oct 29, 1993 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | |||||
Valeant Pharm Intl | SECOBARBITAL SODIUM | secobarbital sodium | CAPSULE;ORAL | 085477-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
>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 North | RETIN-A | tretinoin | CREAM;TOPICAL | 017340-001 | Approved Prior to Jan 1, 1982 | 3,729,568 | ⤷ Subscribe |
Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | 6,254,887 | ⤷ Subscribe |
Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-002 | Dec 30, 1988 | 4,180,582 | ⤷ Subscribe |
Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017579-002 | Approved Prior to Jan 1, 1982 | 3,729,568 | ⤷ Subscribe |
Valeant Pharms North | RENOVA | tretinoin | CREAM;TOPICAL | 021108-001 | Aug 31, 2000 | 4,603,146 | ⤷ Subscribe |
>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 |
---|---|---|
Japan | 2015108021 | ⤷ Subscribe |
Australia | 2011245455 | ⤷ Subscribe |
New Zealand | 593132 | ⤷ Subscribe |
Canada | 3004028 | ⤷ Subscribe |
World Intellectual Property Organization (WIPO) | 2007025146 | ⤷ Subscribe |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Vale Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1458369 | 122008000041 | Germany | ⤷ Subscribe | PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218 |
1304992 | PA2013025 | Lithuania | ⤷ Subscribe | 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 |
1304992 | C01304992/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
1539166 | 13C0062 | France | ⤷ Subscribe | 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 |
1539166 | SPC/GB13/070 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.