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Mylan Pharms Inc Company Profile
What is the competitive landscape for MYLAN PHARMS INC, and when can generic versions of MYLAN PHARMS INC drugs launch?
MYLAN PHARMS INC has two hundred and forty-eight approved drugs.
There are eleven US patents protecting MYLAN PHARMS INC drugs. There are twenty-nine tentative approvals on MYLAN PHARMS INC drugs.
There are one hundred and ninety-one patent family members on MYLAN PHARMS INC drugs in thirty-nine countries and four hundred and thirty-two supplementary protection certificates in fourteen countries.
Summary for Mylan Pharms Inc
| International Patents: | 191 |
| US Patents: | 11 |
| Tradenames: | 204 |
| Ingredients: | 194 |
| NDAs: | 248 |
Drugs and US Patents for Mylan Pharms Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharms Inc | CLINDAMYCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 091225-001 | May 31, 2011 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Mylan Pharms Inc | ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 079161-003 | Jul 19, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Mylan Pharms Inc | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075806-002 | Jul 5, 2002 | AB | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ||||
| Mylan Pharms Inc | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 203802-004 | Sep 24, 2015 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Mylan Pharms Inc | LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 200475-003 | Dec 7, 2015 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Mylan Pharms Inc | TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | CAPSULE;ORAL | 075140-002 | Feb 11, 2000 | 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 Mylan Pharms Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Pharms Inc | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | 6,124,304 | ➤ Sign Up |
| Mylan Pharms Inc | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | 5,840,763 | ➤ Sign Up |
| Mylan Pharms Inc | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | 5,866,581 | ➤ Sign Up |
| Mylan Pharms Inc | MAXZIDE-25 | hydrochlorothiazide; triamterene | TABLET;ORAL | 019129-003 | May 13, 1988 | 4,444,769 | ➤ Sign Up |
| Mylan Pharms Inc | LUXIQ | betamethasone valerate | AEROSOL, FOAM;TOPICAL | 020934-001 | Feb 28, 1999 | 6,126,920 | ➤ Sign Up |
| Mylan Pharms Inc | MAXZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 019129-001 | Oct 22, 1984 | 4,444,769 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for MYLAN PHARMS INC drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Foam | 2% | ➤ Subscribe | 2009-07-30 |
| ➤ Subscribe | Topical Foam | 0.05% | ➤ Subscribe | 2005-06-27 |
| ➤ Subscribe | Foam | 0.12% | ➤ Subscribe | 2007-08-10 |
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
Non-Orange Book US Patents for Mylan 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 |
|---|---|---|
| 8,629,128 | Vitamin formulation | ➤ Sign Up |
| 7,749,488 | Pharmaceutical foam | ➤ Sign Up |
| 6,573,378 | Antiviral guanine derivatives | ➤ Sign Up |
| 8,263,580 | Vitamin formulation | ➤ Sign Up |
| 8,449,867 | Microemulsion and sub-micron emulsion process and compositions | ➤ Sign Up |
| 5,075,445 | Guanine derivatives | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Mylan Pharms Inc Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Denmark | 8504246 | ➤ Sign Up |
| Japan | 2519882 | ➤ Sign Up |
| Mexico | 160431 | ➤ Sign Up |
| Japan | H0586792 | ➤ Sign Up |
| Argentina | 042906 | ➤ Sign Up |
| Australia | 589371 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Mylan Pharms Inc Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB03/034 | United Kingdom | ➤ Sign Up | PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313 |
| C004 | Belgium | ➤ Sign Up | PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925 |
| 2003001,C0740668 | Lithuania | ➤ Sign Up | PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328 |
| 1003503/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006 |
| 00478 | Netherlands | ➤ Sign Up | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 |
| C/GB02/031 | United Kingdom | ➤ Sign Up | PRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/02/212/001-025 20020319 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.
