HALEON US HOLDINGS Company Profile
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What is the competitive landscape for HALEON US HOLDINGS, and when can generic versions of HALEON US HOLDINGS drugs launch?
HALEON US HOLDINGS has thirty-one approved drugs.
There are ten US patents protecting HALEON US HOLDINGS drugs.
There are two hundred and three patent family members on HALEON US HOLDINGS drugs in thirty-two countries and sixteen supplementary protection certificates in eight countries.
Summary for HALEON US HOLDINGS
| International Patents: | 203 |
| US Patents: | 10 |
| Tradenames: | 28 |
| Ingredients: | 18 |
| NDAs: | 31 |
Drugs and US Patents for HALEON US HOLDINGS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | NICORETTE | nicotine polacrilex | GUM, CHEWING;BUCCAL | 018612-002 | Feb 9, 1996 | OTC | Yes | No | 8,323,683 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Haleon Us Holdings | CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 020589-001 | Jun 27, 1996 | OTC | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Haleon Us Holdings | AXID AR | nizatidine | TABLET;ORAL | 020555-001 | May 9, 1996 | OTC | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | |||||
| Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 021330-002 | Oct 31, 2002 | OTC | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | |||||
| Haleon Us Holdings | FLONASE | fluticasone propionate | SPRAY, METERED;NASAL | 020121-001 | Oct 19, 1994 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Haleon Us Holdings | ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen; ibuprofen | TABLET;ORAL | 211733-001 | Feb 28, 2020 | OTC | Yes | Yes | 11,918,693 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >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 HALEON US HOLDINGS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | 6,858,596 | ⤷ Subscribe |
| Haleon Us Holdings | AXID AR | nizatidine | TABLET;ORAL | 020555-001 | May 9, 1996 | 4,375,547 | ⤷ Subscribe |
| Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 022360-001 | May 18, 2009 | 5,110,605 | ⤷ Subscribe |
| Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 021330-002 | Oct 31, 2002 | 5,110,605 | ⤷ Subscribe |
| Haleon Us Holdings | ALLI | orlistat | CAPSULE;ORAL | 021887-001 | Feb 7, 2007 | 4,598,089 | ⤷ Subscribe |
| Haleon Us Holdings | FLONASE | fluticasone propionate | SPRAY, METERED;NASAL | 020121-001 | Oct 19, 1994 | 4,335,121*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for HALEON US HOLDINGS drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 200 mg/38 mg | ➤ Subscribe | 2016-02-16 |
| ➤ Subscribe | Gum | 2 mg | ➤ Subscribe | 2013-01-22 |
| ➤ Subscribe | Capsules | 200 mg/30 mg | ➤ Subscribe | 2004-12-27 |
| ➤ Subscribe | Capsules | 60 mg | ➤ Subscribe | 2010-09-08 |
| ➤ Subscribe | Gum | 4 mg | ➤ Subscribe | 2013-01-22 |
International Patents for HALEON US HOLDINGS Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Turkey | 200501948 | ⤷ Subscribe |
| Poland | 1868731 | ⤷ Subscribe |
| South Korea | 20220027194 | ⤷ Subscribe |
| Poland | 2285411 | ⤷ Subscribe |
| Singapore | 156525 | ⤷ Subscribe |
| Mexico | PA06013919 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HALEON US HOLDINGS Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | 13C0067 | France | ⤷ Subscribe | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
| 2506844 | 18C1022 | France | ⤷ Subscribe | PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
| 2506844 | 132018000000341 | Italy | ⤷ Subscribe | PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117 |
| 1305329 | 08C0014 | France | ⤷ Subscribe | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
| 2506844 | LUC00077 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
| 2506844 | 2018C/022 | Belgium | ⤷ Subscribe | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
| >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.
