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Ani Pharms Inc Company Profile
What is the competitive landscape for ANI PHARMS INC, and when can generic versions of ANI PHARMS INC drugs launch?
There is one US patent protecting ANI PHARMS INC drugs.
There are fourteen patent family members on ANI PHARMS INC drugs in eleven countries and thirty-one supplementary protection certificates in nine countries.
Summary for Ani Pharms Inc
| International Patents: | 14 |
| US Patents: | 1 |
| Tradenames: | 90 |
| Ingredients: | 86 |
| NDAs: | 155 |
Drugs and US Patents for Ani Pharms Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms Inc | CEFADROXIL | cefadroxil/cefadroxil hemihydrate | FOR SUSPENSION;ORAL | 062698-003 | Mar 1, 1989 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Ani Pharms Inc | VANCOCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 062476-001 | Mar 15, 1984 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Ani Pharms Inc | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 201890-004 | Apr 26, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Ani Pharms Inc | ACETOHEXAMIDE | acetohexamide | TABLET;ORAL | 070870-001 | Feb 9, 1987 | 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 Ani Pharms Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ani Pharms Inc | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | 1,712,251 | ➤ Sign Up |
| Ani Pharms Inc | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-003 | May 16, 2008 | 5,721,263 | ➤ Sign Up |
| Ani Pharms Inc | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-001 | Jun 4, 1998 | 5,705,517*PED | ➤ Sign Up |
| Ani Pharms Inc | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-001 | Sep 5, 2000 | 5,721,263 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for ANI PHARMS INC drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 4 mg, 8 mg, 16 mg and 32 mg | ➤ Subscribe | 2006-12-22 |
| ➤ Subscribe | Tablets | 32 mg/25 mg | ➤ Subscribe | 2009-03-06 |
| ➤ Subscribe | Tablets | 16 mg/12.5 mg and 32 mg/12.5 mg | ➤ Subscribe | 2008-06-25 |
Non-Orange Book US Patents for Ani Pharms Inc
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 |
|---|---|---|
| 9,040,086 | Timed, sustained release systems for propranolol | ➤ Sign Up |
| 9,358,214 | Timed, sustained release systems for propranolol | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Ani Pharms Inc Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2005508922 | ➤ Sign Up |
| South Korea | 101090719 | ➤ Sign Up |
| Mexico | PA04003234 | ➤ Sign Up |
| South Korea | 20040084890 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Ani Pharms Inc Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 70044 | Netherlands | ➤ Sign Up | PRODUCT NAME: CANDESARTAN, DESGENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF VAN DE 1-(CYCLOHEXYLOXYCARBONYLOXY) ETHYLESTE R, IN HET BIJZONDER CILEXETILI CANDESARTANAS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: RVG 21703 - RVG 21706 19971013; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429 |
| C/GB12/058 | United Kingdom | ➤ Sign Up | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
| C0021 | Belgium | ➤ Sign Up | PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209 |
| C/GB02/037 | United Kingdom | ➤ Sign Up | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| 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.
