DrugPatentWatch Database Preview
Valeant Company Profile
What is the competitive landscape for VALEANT, and when can generic versions of VALEANT drugs launch?
VALEANT has one hundred and twenty-five approved drugs.
There are forty US patents protecting VALEANT drugs.
There are two hundred and sixty-nine patent family members on VALEANT drugs in forty-six countries and sixty-six supplementary protection certificates in twelve countries.
Summary for Valeant
| International Patents: | 269 |
| US Patents: | 40 |
| Tradenames: | 102 |
| Ingredients: | 80 |
| NDAs: | 125 |
| Patent Litigation for Valeant: | See patent lawsuits for Valeant |
Drugs and US Patents for Valeant
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Intl | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-004 | Dec 8, 1986 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ||||
| Valeant Pharm Intl | ELDECORT | hydrocortisone | CREAM;TOPICAL | 080459-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | 7,662,407 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Valeant Pharms North | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 090071-003 | Apr 15, 2011 | AB | RX | 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 Valeant
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Intl | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-001 | Aug 10, 1992 | 5,470,584 | ➤ Sign Up |
| Valeant Pharms Llc | TASMAR | tolcapone | TABLET;ORAL | 020697-002 | Jan 29, 1998 | 5,236,952 | ➤ Sign Up |
| Valeant Intl | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-006 | Feb 6, 2003 | 5,288,505 | ➤ Sign Up |
| Valeant Pharms North | RETIN-A | tretinoin | CREAM;TOPICAL | 017340-001 | Approved Prior to Jan 1, 1982 | 3,906,108 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for VALEANT drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Rectal Gel | 5 mg/mL, 4mL pre-filled syringe | ➤ Subscribe | 2008-12-08 |
| ➤ Subscribe | Gel | 0.1% | ➤ Subscribe | 2010-07-08 |
| ➤ Subscribe | Extended-release Tablets | 174 mg | ➤ Subscribe | 2009-09-28 |
| ➤ Subscribe | Extended-release Tablets | 120 mg, 180 mg, 240 mg, 300 mg and 360 mg | ➤ Subscribe | 2005-08-30 |
| ➤ Subscribe | Extended-release Tablets | 522 mg | ➤ Subscribe | 2009-12-24 |
| ➤ Subscribe | Extended-release Tablets | 150 mg and 300 mg | ➤ Subscribe | 2004-09-21 |
| ➤ Subscribe | For Inhalation Solution | 6 gm/vial | ➤ Subscribe | 2014-05-22 |
| ➤ Subscribe | Extended-release Tablets | 200 mg | ➤ Subscribe | 2007-03-28 |
| ➤ Subscribe | Extended-release Tablets | 9 mg | ➤ Subscribe | 2013-03-11 |
| ➤ Subscribe | Tablets | 1.1 g | ➤ Subscribe | 2013-11-05 |
| ➤ Subscribe | Rectal Gel | 2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mL | ➤ Subscribe | 2004-03-23 |
| ➤ Subscribe | Rectal Gel | 5 mg/mL, 2mL pre-filled syringe | ➤ Subscribe | 2008-12-23 |
| ➤ Subscribe | Gel | 0.04% | ➤ Subscribe | 2010-12-20 |
| ➤ Subscribe | Extended-release Tablets | 348 mg | ➤ Subscribe | 2009-09-24 |
| ➤ Subscribe | Extended-release Tablets | 420 mg | ➤ Subscribe | 2005-04-25 |
| ➤ Subscribe | Capsules | 75 mg | ➤ Subscribe | 2011-06-06 |
| ➤ Subscribe | Extended-release Tablets | 100 mg | ➤ Subscribe | 2007-01-08 |
| ➤ Subscribe | Extended-release Tablets | 300 mg | ➤ Subscribe | 2007-09-25 |
| ➤ Subscribe | Extended-release Capsules | 0.375 g | ➤ Subscribe | 2012-04-03 |
| ➤ Subscribe | Cream | 0.5% | ➤ Subscribe | 2011-07-29 |
Premature patent expirations for VALEANT
Non-Orange Book US Patents for Valeant
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,932,628 | Modified release formulations of a bupropion salt | ➤ Sign Up |
| 9,592,203 | Controlled release and taste masking oral pharmaceutical composition | ➤ Sign Up |
| 7,645,901 | Modified release formulations of a bupropion salt | ➤ Sign Up |
| 7,884,136 | Modified-release formulations of a bupropion salt | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Valeant Drugs
Supplementary Protection Certificates for Valeant Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0918 | Netherlands | ➤ Sign Up | PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| /2000 | Austria | ➤ Sign Up | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
| 90049-3 | Sweden | ➤ Sign Up | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
| C0013 | Belgium | ➤ Sign Up | PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910 |
| 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.
