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 Pharm Intl | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 080592-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Valeant Pharm Intl | FLUOXYMESTERONE | fluoxymesterone | TABLET;ORAL | 088221-001 | May 5, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Valeant Pharms North | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 075116-001 | Dec 23, 1999 | AB3 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Pharm Intl | FOLIC ACID | folic acid | TABLET;ORAL | 080903-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Valeant Pharm Intl | BENOQUIN | monobenzone | CREAM;TOPICAL | 008173-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Valeant Pharms North | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 075269-002 | Dec 4, 2000 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-001 | Dec 30, 1988 | 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 Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-003 | Dec 30, 1988 | 4,797,405 | ⤷ Sign Up |
| Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-002 | Dec 30, 1988 | 4,166,182 | ⤷ Sign Up |
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | 6,254,887 | ⤷ Sign Up |
| Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017579-002 | Approved Prior to Jan 1, 1982 | 4,247,547 | ⤷ Sign Up |
| Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-001 | Dec 30, 1988 | 4,797,405 | ⤷ Sign Up |
| Valeant Luxembourg | VISUDYNE | verteporfin | INJECTABLE;INJECTION | 021119-001 | Apr 12, 2000 | 4,920,143 | ⤷ Sign Up |
| Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017579-002 | Approved Prior to Jan 1, 1982 | 3,729,568 | ⤷ 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 | 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 |
| ➤ Subscribe | Capsules | 75 mg | ➤ Subscribe | 2011-06-06 |
International Patents for Vale Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20140098863 | ⤷ Sign Up |
| Australia | 2011245455 | ⤷ Sign Up |
| Brazil | PI0615195 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007025146 | ⤷ Sign Up |
| Israel | 189104 | ⤷ Sign Up |
| Brazil | 122014009845 | ⤷ Sign Up |
| Australia | 2007322362 | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218 |
| 1304992 | 1390049-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
| 0617614 | C300043 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011 |
| 1304992 | 132013902214376 | Italy | ⤷ Sign Up | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
| 0186118 | SPC/GB05/029 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218 |
| 0637297 | SPC/GB01/041 | United Kingdom | ⤷ Sign Up | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB01/041 GRANTED TO EISAI R + D MANAGEMENT., LTD. IN RESPECT OF THE PRODUCT BEXAROTENE (4-(1-(3, 5, 5, 8, 8-PENTAMETHYL-5, 6, 7, 8-TETRAHYDRO-2-NAPHTHALENYL)VINYL)BENZOIC ACID), WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 6469 DATED 15/05/2013 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 01/04/2016. |
| 1586316 | SPC/GB11/054 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523 |
| >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.
