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 | LEVO-DROMORAN | levorphanol tartrate | TABLET;ORAL | 008720-001 | Dec 19, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Pharm Intl | QUINIDINE SULFATE | quinidine sulfate | TABLET;ORAL | 083393-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Pharm Intl | BENOQUIN | monobenzone | CREAM;TOPICAL | 008173-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Bermuda | DERMATOP E EMOLLIENT | prednicarbate | CREAM;TOPICAL | 020279-001 | Oct 29, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Valeant Pharms North | RETIN-A | tretinoin | CREAM;TOPICAL | 017340-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Valeant Pharms | PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 075028-001 | Jul 20, 1998 | AB | RX | No | 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 Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | 6,043,279 | ⤷ Try a Trial |
| Valeant Intl | RETIN-A | tretinoin | GEL;TOPICAL | 017955-001 | Approved Prior to Jan 1, 1982 | 3,729,568 | ⤷ Try a Trial |
| Valeant Pharm Intl | DALMANE | flurazepam hydrochloride | CAPSULE;ORAL | 016721-002 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ Try a Trial |
| Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-002 | Dec 30, 1988 | 4,180,582 | ⤷ Try a Trial |
| Valeant Pharm Intl | PERMAX | pergolide mesylate | TABLET;ORAL | 019385-003 | Dec 30, 1988 | 5,114,948 | ⤷ Try a Trial |
| Valeant Pharm Intl | DALMANE | flurazepam hydrochloride | CAPSULE;ORAL | 016721-001 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ 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 | 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 |
|---|---|---|
| Canada | 3004028 | ⤷ Try a Trial |
| European Patent Office | 2563117 | ⤷ Try a Trial |
| China | 101610670 | ⤷ Try a Trial |
| Japan | 6067203 | ⤷ Try a Trial |
| European Patent Office | 1931354 | ⤷ Try a Trial |
| China | 102670626 | ⤷ 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 |
| 1304992 | CR 2013 00053 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
| 1613296 | 92782 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224 |
| 0809498 | 10C0038 | France | ⤷ Try a Trial | PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026 |
| 0617614 | SPC/GB01/014 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018 |
| 0566709 | C300152 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405 |
| >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.
