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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 twenty-five supplementary protection certificates in nine countries.
Summary for Ani Pharms Inc
| International Patents: | 14 |
| US Patents: | 1 |
| Tradenames: | 67 |
| Ingredients: | 63 |
| NDAs: | 126 |
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 | 065278-001 | Jan 20, 2006 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Ani Pharms Inc | PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET;ORAL | 040512-002 | Jul 20, 2005 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Ani Pharms Inc | THIORIDAZINE HYDROCHLORIDE | thioridazine hydrochloride | TABLET;ORAL | 088273-001 | Oct 3, 1983 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Ani Pharms Inc | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075668-002 | Sep 12, 2002 | 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 Ani Pharms Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ani Pharms Inc | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-003 | May 16, 2008 | 5,196,444*PED | ➤ Sign Up |
| Ani Pharms Inc | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | 3,937,838 | ➤ Sign Up |
| Ani Pharms Inc | ATACAND HCT | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 021093-002 | Sep 5, 2000 | 5,196,444*PED | ➤ Sign Up |
| Ani Pharms Inc | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | 4,011,258 | ➤ 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 |
|---|---|---|
| South Korea | 20040084890 | ➤ Sign Up |
| South Korea | 101090719 | ➤ Sign Up |
| Japan | 4369752 | ➤ Sign Up |
| Australia | 2002330211 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Ani Pharms Inc Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0009 | Belgium | ➤ Sign Up | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 |
| 1998 | Austria | ➤ Sign Up | PRODUCT NAME: CANDESARTAN CILEXETIL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-22232, 1-22233, 1-22235, 1-22236 19971119; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429 |
| C0055 | France | ➤ Sign Up | PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811 |
| C0008 | Belgium | ➤ Sign Up | PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204 |
| 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.
