Some Branded Drugs Going Generic In 2018

(RTTNews) - The process of drug development is costly and time consuming. It takes 10 to 15 years, and costs a pharmaceutical company millions to develop and win approval for a new drug. The cost of drug development is $2.6 billion, according to a 2016 report by Tufts Center for the Study of Drug Development. A new drug is covered under patent protection.

A company can apply for patent anywhere along the development lifeline of a drug, and the patent term of a drug runs for 20 years from the date of filing. According to the America Invents Act (AIA), signed into law by President Barack Obama on September 16, 2011, the first to file the patent application, regardless of the date of invention, is granted the patent. This is a shift from the previous "first-to-invent" patent system.

In the U.S., manufacturers of pharmaceutical drugs have the rights to set their own prices for the new drug they develop, in this case, what is called a branded drug, and the on-patent period gives the companies the most advantageous marketing edge.

But the expiry of patents on branded drugs will throw the gate open for competition from relatively inexpensive generic drugs. The generic competition will reduce pricing/market share of the branded drug by more than 80% in less than 12 to 18 months. (Global Generic Pharmaceutical Industry Review - Bank of Tokyo-Mitsubishi UFJ).

Let's take a look at some of the drugs going off patent in 2018, and for which the generic versions are expected to hit the market this year.

1. Acanya Gel for the topical treatment of acne vulgaris.

Acanya Gel (clindamycin phosphate and benzoyl peroxide), developed by Valeant Pharmaceuticals International Inc's (VRX) (VRX.TO) subsidiary, Dow Pharmaceuticals Sciences Inc., is set to lose patent on July 1, 2018. It was approved by the FDA in December 2000.

Under a patent settlement agreement in May 2014, Valeant had granted Actavis a license to market its generic Acanya Gel beginning July 1, 2018. With Actavis being acquired by Teva Pharmaceutical Industries Ltd. (TEVA) in 2016, Teva will be first to market generic Acanya Gel.

Available in ready-to-use pump and in jar, Acanya Gel costs around $500 for one gel pump and $250 for a jar, according to Helprx.info.

Annual market sales of Acanya Gel for the 12 months ended July 2017 were approximately $57 million.

2. Adcirca, an oral treatment for pulmonary arterial hypertension Adcirca (tadalafil), developed by United Therapeutics Corp. (UTHR), loses patent exclusivity on May 21, 2018. It was approved by the FDA in May 2009.

Adcirca costs around $4,193 for a supply of 60 tablets, according to Drugs.com. The drug brought home sales of $372.2 million in full-year 2016 and $99.8 million in Q3, 2017 for United Therapeutics.

Synthon Pharmaceuticals, Aurobindo Pharma Limited and Sun Pharmaceutical Industries have already obtained tentative FDA approval for their generic versions of Adcirca.

3. Ampyra, indicated to improve walking in patients with multiple sclerosis.

The patent covering Acorda Therapeutics Inc.'s (ACOR) Ampyra (dalfampridine) is set to expire in July 2018. The drug was approved by the FDA in January 2010.

Ampyra, which *costs about $1,056 per 30-day supply, recorded sales of $542 million in 2017 compared to $493 million in 2016. (*Data sourced from Drugs.com).

Ten generic drug makers namely, Accord Healthcare Inc., Actavis Laboratories FL Inc., Alkem Laboratories Ltd., Apotex Inc., Aurobindo Pharma Ltd., Mylan Pharmaceuticals Inc., Roxane Laboratories Inc., Teva Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Ltd., and Par Pharmaceutical Inc., have sought approval to market generic versions of Amypra.

4. Cialis, prescribed for the treatment of erectile dysfunction and benign prostatic hyperplasia.

Eli Lilly and Co.'s (LLY) Cialis (tadalafil) goes off the patent in September 2018. It was first approved by the FDA in November 2003. The drug is available in tablet formulation in four dosage strengths: 2.5, 5, 10, and 20 milligrams each.

According to AccessRx, Cialis costs around $43 per tablet for 10 mg dose, and $86 for a 20-milligram tablet. Cialis brought home annual sales of $2.47 billion for Lilly in 2016, and $1.73 billion in sales in the first nine months of 2017.

Zydus Cadila, Aurobindo, Teva Pharmaceutical (TEVA), Alembic, Watson, Sun Pharma and Synthon have received tentative approval to market their generic versions of Cialis.

5. Finacea, indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

Bayer HealthCare's Finacea (azelaic acid) Foam, 15% loses patent protection on November 18, 2018. It was approved by the FDA in July 2015.

Finacea Foam was developed through a research and development collaboration between Bayer and Foamix Pharmaceuticals Ltd. (FOMX). Under the agreement, Foamix receives royalties related to sales of Finacea Foam.

The average retail price of 1 tube (50g) of Finacea is *$379.12 (*Data sourced from GoodRx). Bayer doesn't provide sales details of Finacea in its financial reports.

Glenmark Pharmaceuticals Inc. USA has received tentative approval to market its generic version of Finacea.

6. Fortesta Gel, indicated for treatment of low testosterone, or 'Low T,' also known as hypogonadism.

Endo International plc's (ENDP) topical androgen Fortesta Gel loses patent protection on November 9, 2018. It was approved by the FDA in December 2010.

An authorized generic version of Fortesta Gel was introduced by Endo in September 2014.

Teva has received tentative approval to market its generic version of Fortesta Gel.

7. Levitra, prescribed for the treatment of erectile dysfunction (ED) in men.

Levitra (Vardenafil Hydrochloride), developed by GlaxoSmithKline plc (GSK) and Bayer, loses patent protection on October 31, 2018. It was approved by the FDA in September 2003.

Available as 10 mg and 20 mg tablets, the average retail price for 10 pills of 20 mg of Levitra is $573.82. (Data sourced from GoodRx).

Teva has received tentative approval to market its generic version of Levitra.

8. Lexiva, indicated for the treatment of HIV infections in adults in combination with other antiretroviral medications.

Lexiva, co-discovered by GlaxoSmithKline and Vertex Pharmaceuticals (VRTX) is set to lose patent protection on June 24, 2018. It was approved by the FDA in tablet formulation of dosage 700mg in October 2003, and as an oral suspension (50-mg/mL) in June 2007.

The average wholesale price for 120 tablets of Lexiva (700mg) is $2,408.86. (Data sourced from verywell.com). Lexiva had annual sales of £51 million in 2016, down 26% compared to 2015.

Lupin Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc. (MYL) have received tentative FDA approval to market their generic version of Lexiva.

9. Lyrica, prescribed for the treatment of nerve pain, certain kinds of seizures, and fibromyalgia.

Pfizer Inc.'s (PFE) Lyrica (Pregabalin) is all set to lose patent protection in December 2018. It was first approved by the FDA in December 2004. The drug is available as capsules, oral solution (liquid), and extended-release (long-acting) tablets.

Lyrica had annual sales of $4.96 billion in 2016, and $3.38 billion in the first nine months of 2017. The cost of 30 capsules of Lyrica oral capsule 25 mg is around *$427 (Data sourced from Drugs.com).

Zydus Pharmaceuticals (USA) Inc., Lupin Pharmaceuticals Inc., and Teva Pharmaceuticals are some of the companies that have received tentative approval from the FDA to market their generic version of Lyrica capsules.

10. Rapaflo, prescribed for the treatment of benign prostatic hyperplasia (BPH), or enlarged prostate.

Allergan plc's (AGN) Rapaflo (Silodosin) loses patent protection on December 1, 2018. It was approved by the FDA in October 2008. The drug is available in capsule formulation of 4 mg and 8 mg dosages.

Rapaflo had global annual sales of $122.4 million in 2016, and $85.4 million in the first nine months of 2017. The cost for Rapaflo oral capsule 4 mg is around $269 for a supply of 30 capsules (*Drugs.com).

Sandoz Inc., and Lupin Limited have received tentative approval from the FDA to market their generic version of Rapaflo.

11. Remodulin, indicated to treat pulmonary arterial hypertension.

Remodulin (treprostinil) injection, developed by United Therapeutics (UTHR), loses patent protection in June 2018. It was approved by the FDA in May 2002.

Remodulin, which is supplied in 20 mL vials, costs around $1,291 (Drugs.com). The net product sales of Remodulin were $602.3 million in full year 2016, and $490.8 million in the first nine months of 2017.

Sandoz Inc has a non-exclusive license to manufacture and commercialize the generic version of Remodulin beginning on June 26, 2018. Teva, Par Sterile Products LLC and Dr. Reddy's can each market their generic versions of Remodulin in the United States beginning in December 2018.

12. Sensipar, prescribed for the treatment of secondary hyperparathyroidism in dialysis patients.

Amgen's (AMGN) Sensipar (cinacalcet) loses patent protection in March 2018. The drug was approved by the FDA in March 2004, and is available in tablet formulation of dosage strengths 30, 60 and 90mg.

Total Sensipar sales were $1.58 billion in full year 2016, and $1.30 billion in the nine months of 2017. It costs $851 for 30 tablets of Sensipar 30 mg (Data sourced from Drugs.com)

Aurobindo Pharma Limited, Mylan and Teva have received tentative approval from the FDA to market their generic versions of Sensipar.

13. Treximet, prescribed for migraine.

Treximet, (Sumatriptan 10mg and Naproxen Sodium 60mg), co-developed by GlaxoSmithKline (GSK) and Pozen, loses patent protection on February 14, 2018. It was approved by the FDA in April 2008, and is available in tablet formulation.

GlaxoSmithKline sold its U.S. rights to Treximet to Pernix Therapeutics (PTX) in 2014. Pozen merged with Tribute Pharmaceuticals to create a new company by the name Aralez Pharmaceuticals Inc. (ARLZ) in February 2016.

The drug brought home sales of $67.0 million for Pernix in full-year 2016, and $50.4 million in the first nine months of 2017. According to Drugs.com, the cost of 9 tablets of Treximet 10/60 mg is around $927.

Six companies sought FDA approval to market a generic version of Treximet, and three have been permitted to launch their generic versions of the migraine drug in 2018.

14. VESIcare, indicated for the treatment of overactive bladder.

Astellas Pharma Inc.'s (ALPMY) VESIcare (Solifenacin succinate) is set to go off patent in November 2018. It was approved by the FDA in November 2004, and is available in tablet formulation of 5mg and 10mg strengths.

According to IMS Health sales data for the 12 month period ending April 2017, VESIcare achieved annual sales of approximately $1.1 billion. The drug costs around $367 per 30 tablets, according to Drugs.com.

Glenmark, Teva and Ajanta Pharma have received tentative approval for the generic version of VESIcare.

Conclusion:

In *fiscal 2017, the FDA greenlighted 763 generic drugs, and gave tentative approval to an additional 174 generic drugs. There were 1,292 ANDA filings in fiscal 2017. The numbers compare favorably with that of fiscal 2016, which saw only 852 ANDA filings and 651 generic drug approvals. (Fiscal 2017 is the period between October 1, 2016 to September 30, 2017).

Generic drugs cost lesser than their brand-name counterparts because the expenses involved are relatively smaller as the manufacture of generic drugs is devoid of the lengthy research and testing process.

Over the last decade alone, the U.S. healthcare system has saved $1.67 trillion due to the availability of low-cost generics, according to the 2017 Generic Drug Access and Savings Report. Even greater cost savings can be achieved if a more efficient generic drug review process is in place feels the FDA Commissioner Scott Gottlieb, and the regulatory agency is taking steps to achieve this goal.

Reference:

Drugs Coming Off Patent by 2022: National Pharmaceutical Services